| 1. |
- Hagberg, Kerstin, 1957, et al.
(author)
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Reproducibility of the physiological cost index among individuals with a lower-limb amputation and healthy adults
- 2011
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In: Physiotherapy Research International. - 1471-2865. ; 16:2, s. 92-100
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Journal article (peer-reviewed)abstract
- Background and Purpose.The physiological cost index (PCI) is a clinical measurement used to estimate the energy cost of walking. The reproducibility of the PCI has been questioned and no study has investigated the measurement error among individuals with a lower-limb amputation. The aim was to investigate the test–retest reproducibility of the PCI in individuals with a lower-limb amputation and healthy adults. Methods.The study comprised 28 individuals (20 males, eight females, mean age 49 years) with a unilateral amputation due to reasons other than vascular disease and 31 healthy volunteers (20 males, 11 females, mean age 47 years). PCI values were obtained by registering heart rate at rest and during level indoor walking for 5 minutes at a comfortable speed. A within-day test–retest assessment was performed. Reproducibility analyses included intra-class correlation, analyses of systematic differences between measurements, calculation of the smallest detectable change (SDC) and coefficient of variation (CV), and the results were finally visualized using Bland–Altman plots. Results.The reliability in terms of intra-class correlation was excellent for both groups (0.966 and 0.948). In the amputee group, the PCI revealed a mean difference of 0.026 (p = 0.016) between tests (PCI = 0.555, standard deviation [SD] = 0.214 and PCI = 0.581, SD = 0.236, respectively). In the healthy group, there was no systematic difference between tests (PCI = 0.329, SD = 0.114 and PCI = 0.331, SD = 0.110, respectively). The SDC was 0.116 in the amputee group and 0.070 in the healthy group, giving a CV of 20.4% and 21.0%,respectively. Conclusions.The within-day test–retest reproducibility of the PCI was excellent among individuals with lower-limb amputations and healthy adults in terms of intra-class correlation and acceptable in terms of agreement. The SDC, which was calculated for each group, should be considered when demonstrating an individual difference after an intervention. Copyright © 2010 John Wiley & Sons, Ltd
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| 2. |
- Tillander, Jonatan, 1975, et al.
(author)
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Osseointegrated titanium implants for limb prostheses attachments: infectious complications.
- 2010
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In: Clinical orthopaedics and related research. - : Ovid Technologies (Wolters Kluwer Health). - 1528-1132 .- 0009-921X. ; 468:10, s. 2781-2788
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Journal article (peer-reviewed)abstract
- BACKGROUND: The concept of osseointegration involves direct contact between titanium implant and bone. This transcutaneous prosthetic system for amputees is intended to assure stable long-term fixation. Most metal transcutaneous implants have failed, primarily owing to infection. QUESTIONS/PURPOSES: We determined the frequency and describe the presentation of infectious complications with this novel method. We also evaluated the bacterial flora at the skin-penetration area and its relation to the development of local and implant-related infection. PATIENTS AND METHODS: We prospectively followed 39 patients with arm and leg amputations fitted with transcutaneous osseointegrated titanium implants a mean of 56 months earlier (range, 132-133 months). There were 33 femoral, one tibial, four ulnar, four radial, and three humeral implants. Patients were selected during a 6-month period in 2005 and identically reevaluated after 3 years. Implant infection was defined as definite, probable, or possible based on clinical, radiologic, and microbiologic evidence. RESULTS: The frequency of implant infection was 5% at inclusion and 18% at followup. One patient with infection recovered owing to antibiotic treatment and another patient had the implant removed. Most implant infections had low infectious activity, and in five of the seven patients with infections, prosthetic use was not affected. The most common bacteria in superficial and deep cultures were Staphylococcus aureus and coagulase-negative staphylococci. CONCLUSIONS: Despite frequent colonization around the skin-implant interface by potentially virulent bacteria such as Staphylococcus aureus and bacteria associated with biomedical device infections such as coagulase-negative staphylococci, this titanium implant system for bone-anchored prostheses caused few infections leading to disability or implant removal. LEVEL OF EVIDENCE: Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.
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| 3. |
- Tillander, Jonatan, 1975, et al.
(author)
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Osteomyelitis Risk in Patients With Transfemoral Amputations Treated With Osseointegration Prostheses.
- 2017
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In: Clinical orthopaedics and related research. - : Ovid Technologies (Wolters Kluwer Health). - 1528-1132 .- 0009-921X. ; 475:12, s. 3100-3108
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Journal article (peer-reviewed)abstract
- Percutaneous anchoring of femoral amputation prostheses using osseointegrating titanium implants has been in use for more than 25years. The method offers considerable advantages in daily life compared with conventional socket prostheses, however long-term success might be jeopardized by implant-associated infection, especially osteomyelitis, but the long-term risk of this complication is unknown.(1) To quantify the risk of osteomyelitis, (2) to characterize the clinical effect of osteomyelitis (including risk of implant extraction and impairments to function), and (3) to determine whether common patient factors (age, sex, body weight, diabetes, and implant component replacements) are associated with osteomyelitis in patients with transfemoral amputations treated with osseointegrated titanium implants.We retrospectively analyzed our first 96 patients receiving femoral implants (102 implants; mean implant time, 95months) treated at our center between 1990 and 2010 for osteomyelitis. Six patients were lost to followup. The reason for amputation was tumor, trauma, or ischemia in 97 limbs and infection in five. All patients were referred from other orthopaedic centers owing to difficulty with use or to be fitted with socket prostheses. If found ineligible for this implant procedure no other treatment was offered at our center. Osteomyelitis was diagnosed by medical chart review of clinical signs, tissue culture results, and plain radiographic findings. Proportion of daily prosthetic use when osteomyelitis was diagnosed was semiquantitatively graded as 1 to 3. Survivorship free from implant- associated osteomyelitis and extraction attributable to osteomyelitis respectively was calculated using the Kaplan-Meier estimator. Indication for extraction was infection not responsive to conservative treatment with or without minor débridement or loosening of implant.Implant-associated osteomyelitis was diagnosed in 16 patients corresponding to a 10-year cumulative risk of 20% (95% CI 0.12-0.33). Ten implants were extracted owing to osteomyelitis, with a 10-year cumulative risk of 9% (95% CI 0.04-0.20). Prosthetic use was temporarily impaired in four of the six patients with infection who did not undergo implant extraction. With the numbers available, we did not identify any association between age, BMI, or diabetes with osteomyelitis; however, this study was underpowered on this endpoint.The increased risk of infection with time calls for numerous measures. First, patients should be made aware of the long-term risks, and the surgical team should have a heightened suspicion in patients with method-specific presentation of possible infection. Second, several research questions have been raised. Will the surgical procedure, rehabilitation, and general care standardization since the start of the program result in lower infection rates? Will improved diagnostics and early treatment resolve infection and prevent subsequent extraction? Although not supported in this study, it is important to know if most infections arise as continuous bacterial invasion from the skin and implant interface and if so, how this can be prevented?Level IV, therapeutic study.
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| 4. |
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| 5. |
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| 6. |
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| 7. |
- Brånemark, Rickard, 1960, et al.
(author)
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A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: A prospective study of 51 patients.
- 2014
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In: The bone & joint journal. - 2049-4408. ; 96:1, s. 106-13
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Journal article (peer-reviewed)abstract
- Patients with transfemoral amputation (TFA) often experience problems related to the use of socket-suspended prostheses. The clinical development of osseointegrated percutaneous prostheses for patients with a TFA started in 1990, based on the long-term successful results of osseointegrated dental implants. Between1999 and 2007, 51 patients with 55 TFAs were consecutively enrolled in a prospective, single-centre non-randomised study and followed for two years. The indication for amputation was trauma in 33 patients (65%) and tumour in 12 (24%). A two-stage surgical procedure was used to introduce a percutaneous implant to which an external amputation prosthesis was attached. The assessment of outcome included the use of two self-report questionnaires, the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA) and the Short-Form (SF)-36. The cumulative survival at two years' follow-up was 92%. The Q-TFA showed improved prosthetic use, mobility, global situation and fewer problems (all p < 0.001). The physical function SF-36 scores were also improved (p < 0.001). Superficial infection was the most frequent complication, occurring 41 times in 28 patients (rate of infection 54.9%). Most were treated effectively with oral antibiotics. The implant was removed in four patients because of loosening (three aseptic, one infection). Osseointegrated percutaneous implants constitute a novel form of treatment for patients with TFA. The high cumulative survival rate at two years (92%) combined with enhanced prosthetic use and mobility, fewer problems and improved quality of life, supports the 'revolutionary change' that patients with TFA have reported following treatment with osseointegrated percutaneous prostheses. Cite this article: Bone Joint J 2014;96-B:106-13.
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| 8. |
- Brånemark, Rickard, 1960, et al.
(author)
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Osseointegrated Percutaneous Prosthetic System for the Treatment of Patients With Transfemoral Amputation: A Prospective Five-year Follow-up of Patient-reported Outcomes and Complications
- 2019
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In: Journal of the American Academy of Orthopaedic Surgeons. - 1067-151X.
-
Journal article (peer-reviewed)abstract
- INTRODUCTION: Direct skeletal attachment of prostheses has previously been shown to improve patient-reported outcome (PRO) measures of individuals with transfemoral amputation (TFA) at 2-year follow-up. This prospective study reports the outcomes at 5-year follow-up. METHODS: A total of 51 patients (55 legs) with TFA were included in a prospective study. Complications, success rate, and PRO measures were followed for 5 years. RESULTS: The cumulative fixture survival rate at 5 years was 92%, and the revision-free survival rate was 45%. Thirty-four patients had 70 superficial infections. Eleven patients had 14 deep infections. Fifteen patients had mechanical complications. Four fixtures were removed (ie, one deep infection and three loosening). PRO measures showed significant improvements including more use of the prosthesis, better mobility, fewer issues, and improved physical health-related quality of life (all P < 0.0001) compared with baseline. CONCLUSION: Individuals with TFA at 5-year follow-up had significant improvement in PRO measures, but increases in deep infections and mechanical complications are concerning.This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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| 9. |
- Ernstsson, O., et al.
(author)
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Health-related quality of life in patients with lower limb amputation - an assessment of the measurement properties of EQ-5D-3L and EQ-5D-5L using data from the Swedish Amputation and Prosthetics Registry
- 2022
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In: Disability and Rehabilitation. - : Informa UK Limited. - 0963-8288 .- 1464-5165. ; 44:26, s. 8471-8479
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Journal article (peer-reviewed)abstract
- Purpose To assess the measurement properties of EQ-5D-3L and EQ-5D-5L in patients with a major lower limb amputation (LLA). Methods This was a retrospective register-based study using data from the Swedish Amputation and Prosthetics Registry (SwedeAmp). Patients with a six-months follow-up (including either EQ-5D-3L or EQ-5D-5L) after a major unilateral LLA were included. The measurement properties of EQ-5D-3L and EQ-5D-5L were compared in terms of feasibility, response patterns, informativity, and convergent and known-group validity. Results The sample included 700 patients with below-knee amputation (76%), above-knee amputation (18%), or knee disarticulation (7%). Responses to EQ-5D-3L and -5L were similar regarding feasibility (98% completion rate) and the proportion reporting no problems (7% and 6%). Compared to EQ-5D-3L, EQ-5D-5L showed higher absolute and relative informativity in all dimensions, with the largest improvement in the mobility dimension. In the analyses of convergent validity, the EQ-5D-5L generally showed stronger correlations with disease-specific measures. Only EQ-5D-5L was able to discriminate between subgroups with different amputation levels. Conclusion The findings support the use of EQ-5D-5L over EQ-5D-3L in patients with an LLA, mainly due to improved informativity and improved convergent and known-group validity.
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| 10. |
- Frossard, L., et al.
(author)
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Apparatus for monitoring load bearing rehabilitation exercises of a transfemoral amputee fitted with an osseointegrated fixation: a proof-of-concept study
- 2010
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In: Gait & Posture. - : Elsevier BV. - 1879-2219 .- 0966-6362. ; 31:2, s. 223-228
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Journal article (peer-reviewed)abstract
- The purpose of this proof-of-concept study was to determine the relevance of direct measurements to monitor the load applied on the osseointegrated fixation of transfemoral amputees during static load bearing exercises. The objectives were (A) to introduce an apparatus using a three-dimensional load transducer, (B) to present a range of derived information relevant to clinicians, (C) to report on the outcomes of a pilot study and (D) to compare the measurements from the transducer with those from the current method using a weighing scale. One transfemoral amputee fitted with an osseointegrated implant was asked to apply 10 kg, 20 kg, 40 kg and 80 kg on the fixation, using self-monitoring with the weighing scale. The loading was directly measured with a portable kinetic system including a six-channel transducer, external interface circuitry and a laptop. As the load prescribed increased from 10 kg to 80 kg, the forces and moments applied on and around the antero-posterior axis increased by four-fold anteriorly and 14-fold medially, respectively. The forces and moments applied on and around the medio-lateral axis increased by nine-fold laterally and 16-fold from anterior to posterior, respectively. The long axis of the fixation was overloaded and underloaded in 17% and 83% of the trials, respectively, by up to + or - 10%. This proof-of-concept study presents an apparatus that can be used by clinicians facing the challenge of improving basic knowledge on osseointegration, for the design of equipment for load bearing exercises and for rehabilitation programs.
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| 11. |
- Frossard, L., et al.
(author)
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Load applied on bone-anchored transfemoral prosthesis: Characterization of a prosthesis-A pilot study
- 2013
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In: Journal of Rehabilitation Research and Development. - : Journal of Rehabilitation Research & Development. - 0748-7711. ; 50:5, s. 619-634
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Journal article (peer-reviewed)abstract
- The objectives of this study were to (1) record the inner-prosthesis loading during activities of daily living (ADLs), (2) present a set of variables comparing loading data, and (3) provide an example of characterization of two prostheses. The load was measured at 200 Hz using a multi-axial transducer mounted between the residuum and the knee of an individual with unilateral transfemoral amputation fitted with a bone-anchored prosthesis. The load was measured while using two different prosthetic knees, mechanical (PRO1) and microprocessor-controlled (PRO2), during six ADLs. The characterization of the prostheses was achieved using a set of variables split into four categories, including temporal characteristics, maximum loading, loading slopes, and impulse. Approximately 360 gait cycles were analyzed for each prosthesis. PRO I showed a cadence improved by 19% and 7%, a maximum force on the long axis reduced by 11% and 19%, and an impulse reduced by 32% and 15% during descent of incline and stairs compared with PRO2, respectively. This work confirmed that the proposed apparatus and characterization can reveal how changes of prosthetic components are translated into inner-prosthetic loading.
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| 12. |
- Frossard, Laurent, et al.
(author)
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Load-relief of walking AIDS on osseointegrated fixation: instrument for evidence-based practice.
- 2009
-
In: IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society. - 1558-0210. ; 17:1, s. 9-14
-
Journal article (peer-reviewed)abstract
- Clinicians are currently in demand of tools enabling individual assessment during their daily practice of load-relief of walking aids. The first aim of this article is to describe a portable kinetic system that could be used to measure directly the true load applied on the residuum during assisted walking. The second aim is to present the information that can be derived from the raw loading data. The third aim is to provide an example for a participant. One active transfemoral amputee fitted with an osseointegrated fixation was asked to walk in straight level line with no aid, one stick, one and two elbow crutches on a 20 m walkway. The load-relief was measured using a six-channel transducer and recorded using a data logger. The overall loading was decreased by 2% using one stick, 5% using one crutch and by 10% using two crutches. This study presents a method that can be used by clinicians facing the challenge of prescribing and assessing walking aids to restore the locomotion of lower limb amputees in the framework of an evidence-based practice.
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| 13. |
- Frossard, L., et al.
(author)
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Monitoring of the load regime applied on the osseointegrated fixation of a trans-femoral amputee: a tool for evidence-based practice
- 2008
-
In: Prosthetics and Orthotics International. - 1746-1553. ; 32:1, s. 68-78
-
Journal article (peer-reviewed)abstract
- This study aimed to provide a description of the continuous recording of the true load regime experienced during daily living by the abutment of a trans-femoral amputee fitted with an osseointegrated fixation. The specific objectives: (i) To present an apparatus and a procedure allowing recording of the load regime, and (ii) an example of the raw data and six performance indicators of the usage of the prosthesis obtained with this method. A subject was monitored for a period of 5 hours as he went about his daily activities. The load regime was directly measured and recorded using a commercial transducer and data logger. The overall load profile presented alternative periods of variable length of inactivity (64%) and activity (36%), respectively. The maximum load applied on the mediolateral, anteroposterior and the long axes represented 21%, 21% and 120% of the body weight, respectively. The anteroposterior, mediolateral and long components of the impulse were 395 kN.s, 359 kN.s and 2,323 kN.s, respectively. The amputee generated a total of 2312 gait cycles of the prosthetic leg, giving an approximate overall cadence of 8 stride/min. Preliminary outcomes indicated that the proposed method was an improvement on the current techniques as it provided the true loading and actual usage of the prosthesis during daily living. This study is a stepping stone in the development of future affordable, on-board and user-friendly load recording systems that can be used in evidence-based practice.
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| 14. |
- Hagberg, Kerstin, 1957, et al.
(author)
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A 15-year follow-up of transfemoral amputees with bone-anchored transcutaneous prostheses. Mechanical complications and patient-reported outcomes
- 2020
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In: Bone & Joint Journal. - 2049-4394. ; 102B:1, s. 55-63
-
Journal article (peer-reviewed)abstract
- Aims The aim of this study was to describe implant and patient-reported outcome in patients with a unilateral transfemoral amputation (TFA) treated with a bone-anchored, transcutaneous prosthesis. Patients and Methods In this cohort study, all patients with a unilateral TFA treated with the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) implant system in Sahlgrenska University Hospital, Gothenburg, Sweden, between January 1999 and December 2017 were included. The cohort comprised 111 patients (78 male (70%)), with a mean age 45 years (17 to 70). The main reason for amputation was trauma in 75 (68%) and tumours in 23 (21%). Patients answered the Questionnaire for Persons with Transfemoral Amputation (Q-TFA) before treatment and at two, five, seven, ten, and 15 years' follow-up. A prosthetic activity grade was assigned to each patient at each timepoint. All mechanical complications, defined as fracture, bending, or wear to any part of the implant system resulting in removal or change, were recorded. Results The Q-TFA scores at two, five, seven, and ten years showed significantly more prosthetic use, better mobility, fewer problems, and an improved global situation, compared with baseline. The survival rate of the osseointegrated implant part (the fixture) was 89% and 72% after seven and 15 years, respectively. A total of 61 patients (55%) had mechanical complications (mean 3.3 (SD 5.76)), resulting in exchange of the percutaneous implant parts. There was a positive relationship between a higher activity grade and the number of mechanical complications. Conclusion Compared with before treatment, the patient-reported outcome was significantly better and remained so over time. Although osseointegration and the ability to transfer loads over a 15-year period have been demonstrated, a large number of mechanical failures in the external implant parts were found. Since these were related to higher activity, restrictions in activity and improvements to the mechanical properties of the implant system are required.
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| 15. |
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| 16. |
- Hagberg, Kerstin, 1957
(author)
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Bone-anchored prostheses in patients with traumatic bilateral transfemoral amputations: rehabilitation description and outcome in 12 cases treated with the OPRA implant system
- 2019
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In: Disability and Rehabilitation-Assistive Technology. - : Informa UK Limited. - 1748-3107 .- 1748-3115. ; 14:4, s. 346-353
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Journal article (peer-reviewed)abstract
- Purpose: To describe the rehabilitation experience and outcome of treatment with bone-anchored prostheses in individuals with bilateral transfemoral amputations (TFAs) treated in Sweden over a period of 25 years. Method: Hospital records were reviewed for all patients with traumatic bilateral TFAs treated until 2015. The use of prostheses, walking aids and wheelchairs was noted. Results: The cohort comprised 12 patients (nine men and three women with a mean age 35 years at treatment) and the median follow-up time was seven years (1-20). At baseline, 9/12 used prostheses and 3/12 did not. The main means of locomotion was in a wheelchair without wearing prostheses (n=8/12) or in a wheelchair in combination with prosthetic walking supported by walking aids (n=4/12). All prosthetic users had problems with sitting comfort. At follow-up, 11/12 patients used prostheses, while one did not. The means of locomotion was prosthetic walking in 3/12 cases, a combination of a wheelchair and prosthetic walking in 4/12, a wheelchair while wearing prostheses but not walking in 4/12 and a wheelchair without wearing prostheses in 1/12. Three patients walked unsupported by walking aids. Seven patients had no problem with prosthetic sitting comfort (n=3 had small problems). Conclusions: Bone-anchored prostheses in patients with bilateral TFAs resulted in more prosthesis use during everyday locomotion, due hypothetically to improved comfort while wearing prostheses. The results further underline the importance of other assistive devices such as wheelchairs and walking aids used in combination with prostheses in this group of patients facing severe functional limitations.
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| 17. |
- Hagberg, Kerstin, 1957, et al.
(author)
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Consequences of non-vascular trans-femoral amputation: a survey of quality of life, prosthetic use and problems.
- 2001
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In: Prosthetics and orthotics international. - 0309-3646. ; 25:3, s. 186-94
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Journal article (peer-reviewed)abstract
- Individuals with unilateral trans-femoral amputations due to non-vascular causes were studied in a mailed survey designed to investigate health-related quality of life (HRQL), prosthetic use and problems. The Swedish SF-36 Health Survey and a structured questionnaire designed for trans-femoral amputees were used. The series consisted of 97 subjects (60 men, 37 women), aged 20 to 69 years with a mean of 22 years since the amputation. Trauma was the cause of amputation in 55%, tumour in 35% and other causes in 10%. Ninety-two (92) subjects (95%) had a prosthesis and 80 (82%) used it daily. General HRQL was significantly lower than Swedish age- and gender-matched norms in all dimensions as measured by SF-36. Most frequently reported problems that had led to reduction in quality of life were heat/sweating in the prosthetic socket (72%), sores/skin irritation from the socket (62%), inability to walk in woods and fields (61%) and inability to walk quickly (59%). Close to half were troubled by stump pain (51%), phantom limb pain (48%), back pain (47%) and pain in the other leg (46%). One fourth considered themselves to have a poor or extremely poor overall situation. Transfemoral amputation, due to non-vascular causes, has an evident impact on quality of life and there are considerable problems related to the amputation and the prosthesis. Efforts to improve the physical and the psychological well-being for this group, with a long life expectancy, are needed.
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| 18. |
- Hagberg, Kerstin, 1957, et al.
(author)
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Daily Activity of Individuals With an Amputation Above the Knee as Recorded From the Nonamputated Limb and the Prosthetic Limb
- 2023
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In: Journal for the Measurement of Physical Behaviour. - 2575-6605 .- 2575-6613. ; 6:3, s. 223-232
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Journal article (peer-reviewed)abstract
- Introduction: Mobility restriction following limb loss might lead to a sedentary lifestyle, impacting health. Daily activity monitoring of amputees has focused on prosthetic steps, neglecting overall activity. Purpose: Toassessdailyactivityinindividualswithan established amputation and to explore the amount of activity recorded from the prosthesis as compared to the overall activity. Methods: Individuals with a unilateral transfemoral amputation or knee disarticulation who had used a prosthesis in daily life for >1 yearand could walk 100 m (unsupported or single aided) were recruited. Descriptive information and prosthetic mobility were collected. Two activPAL™ accelerometers were attached to the nonamputated thigh and the prosthesis, respectively. The mean daily activity over 7 days was compared between the nonamputated limb and the prosthesis. Results: Thirty-nine participants (22 men/17 women; mean age 54 [14.5] years) with amputation mainly due to trauma (59%) or tumor (28%) were included. Overall, participants took 6,125 steps and spent 10.2 hr sedentary, 5.0 hr upright, and 8.7 hr laying per day. Compared to recordings from the nonamputated limb, 85% of sit-to-stand transitions (32/38), 73% of steps (4,449/6,125), and 68% of walking time (1.0/1.5 hr) were recorded from the prosthesis. Recordings seemed to be less adequate for incidental prosthetic steps than for walks. Conclusions: Sedentary behavior accounted for most of the day demonstrating the importance to encourage physical activity among established prosthetic users. The prosthesis is used for daily activity to a great extent. However, noted pitfalls in the recordings call for further refinement of the measurements.
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| 19. |
- Hagberg, Kerstin, 1957, et al.
(author)
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One hundred patients treated with osseointegrated transfemoral amputation prostheses--rehabilitation perspective
- 2009
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In: J Rehabil Res Dev. - 1938-1352. ; 46:3, s. 331-44
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Journal article (peer-reviewed)abstract
- Treatment with osseointegrated transfemoral prostheses has been shown to improve quality of life. The treatment has been performed in Sweden since 1990 and consists of two surgical procedures followed by rehabilitation. During the first years, the rehabilitation process was not standardized. In 1999, a treatment protocol called OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) was established. This article describes the current rehabilitation protocol and illustrates the overall results. The OPRA rehabilitation protocol is graded to stimulate the process of osseointegration and prepare the patient for unrestricted prosthetic use. It includes initial training with a short training prosthesis followed by gradually increased prosthetic activity. Between May 1990 and June 2008, we treated 100 patients with 106 implants (6 bilaterally; 61% males, 39% females; mean age 43 years; mean time since amputation 11.5 years.) The majority had amputations due to trauma (67%) or tumor (21%) (other = 12%). Currently, 68 patients are using their prostheses (follow-up: 3 months- 17.5 years) and 32 are not (4 are deceased, 7 are before second surgery, 6 are in initial training, 4 are not using prosthesis, and 11 had the implant removed). The majority of treatment failures occurred in patients before we established the OPRA protocol. The implementation of graded rehabilitation is considered to be of utmost importance for improved results.
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| 20. |
- Hagberg, Kerstin, 1957, et al.
(author)
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Osseointegrated prostheses for the rehabilitation of patients with transfemoral amputations: A prospective ten-year cohort study of patient-reported outcomes and complications
- 2023
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In: Journal of Orthopaedic Translation. - : Elsevier BV. - 2214-031X. ; 38, s. 56-64
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Journal article (peer-reviewed)abstract
- Background: Osseointegrated implants for patients with transfemoral amputations (TFAs) are a novel treatment under development, and prospective long-term evidence is lacking. The objectives were to determine patient -reported outcomes (PROs) and complications after ten years compared to before treatment and to compare the first five-year period with the later five-year period with regard to the outcomes. Methods: In a nonrandomized, prospective cohort study, patients with TFAs treated between 1999 and 2007 with the Osseointegrated Prosthesis for the Rehabilitation of Amputees (OPRA) system (n = 51) (28 men/23 women; mean age at amputation: 32 years old; mean age at treatment: 44 years old in a single university hospital were followed for ten years. PROs included the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA, four scores 0-100) and the Short Form 36 Health Survey (SF-36, ten scores 0-100) and were answered before treatment and until the ten-year follow-up after treatment. Analyses of differences in PRO scores were conducted using Wilcoxon's signed rank test. The implant survival and revision-free rates with respect to adverse events (implant revision, mechanical complications, and deep infections) were presented as Kaplan-Meier graphs with 95% confidence intervals (CIs). The incidences of events per ten and five person-years were calculated. Spear -man's correlation analysis was used for analyses of associations between adverse events. Results: PROs showed statistically significant mean improvements between baseline and the ten-year follow-up with regard to all Q-TFA scores: the prosthetic use score (+36), prosthetic mobility score (+18), problem score (-28) and global score (+38) (all p < 0.001), and the SF-36 physical functioning score (+26, p < 0.001) and physical component score (+6, p < 0.01). No PROs showed a statistically significant deterioration. Over the ten years, 12 patients were lost (one lost to follow-up, one dropped out of the study, two died, and eight had implants removed (four before five years and four between five and ten years). At ten years, the revision-free survival rates were 83% (CI: 69%-91%), 65% (CI: 49%-77%) and 17% (CI: 7%-29%) for implant revision, deep infection and mechanical complications, respectively. Mechanical complications, 3.9 per 10 person-years (CI: 2.2-5.1) consti-tuted the most common serious adverse event and were more common during the last five years than during the first five years (p < 0.001). No significant difference in the incidence of deep infections was observed between the earlier and the later five-year periods: 0.3 per 5 person-years (CI: 0.1-0.5) vs. 0.3 per person-years (CI: 0.1-0.5) (p = 0.740). Correlation analyses between the earlier and later five years revealed a positive association between deep infections and implant removal (0.57, p < 0.001) and between mechanical complications and adverse events (0.65, p < 0.001). Conclusion: Improved PROs were demonstrated ten years after the introduction of a novel principle for bone anchorage of amputation prostheses. Nevertheless, an increasing rate of mechanical complications is of concern.
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| 21. |
- Hagberg, Kerstin, 1957, et al.
(author)
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Osseointegrated trans-femoral amputation prostheses: prospective results of general and condition-specific quality of life in 18 patients at 2-year follow-up
- 2008
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In: Prosthetics and Orthotics International. - : Ovid Technologies (Wolters Kluwer Health). - 1746-1553 .- 0309-3646. ; 32:1, s. 29-41
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Journal article (peer-reviewed)abstract
- This is the first report on prospective outcome for individuals treated with bone-anchored trans-femoral amputation prostheses (OI-prostheses) using the method of osseointegration. The aim was to analyze general and condition-specific health related quality of life (HRQL) at 2-year follow-up as compared to the preoperative situation. The study population consists of the first 18 consecutively treated patients (8 male/10 female, mean age 45 years) in a clinical investigation with amputations mainly caused by trauma and tumour. At inclusion the mean time since the amputation was 15 years (10 months - 33 years). Two self-report questionnaires were answered preoperatively and at follow-up: the SF-36 Health Survey (SF-36) and the Questionnaire for persons with a Transfemoral Amputation (Q-TFA). At follow-up 17/18 patients used the OI-prosthesis; one did not due to pain and loosening of the implant. Four of the scales of the SF-36 (Physical Functioning, Role Functioning Physical, Bodily Pain and Physical Component Score) and all four scores of Q-TFA (Prosthetic Use, Prosthetic Mobility, Problems and Global Health) were statistically significantly improved at follow-up showing superior general physical HRQL, increased prosthetic use, better prosthetic mobility, fewer problems and a better global amputation situation. Thus, osseointegrated prostheses represent a promising development in the rehabilitation of individuals with transfemoral amputation and increase their quality of life.
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| 22. |
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| 23. |
- Hagberg, Kerstin, 1957, et al.
(author)
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Patient-reported benefits of bone-anchored transfemoral prostheses as assessed by MedTech20: A general outcome measure for medical products
- 2021
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In: Prosthetics and orthotics international. - 1746-1553. ; 45:4, s. 355-361
-
Journal article (peer-reviewed)abstract
- BACKGROUND: The medical community demands evidence for the benefits of medical devices such as bone-anchored prostheses (BAPs). MedTech20 is a novel instrument aiming to address general benefits of medical devices. OBJECTIVE: To describe general patient-reported benefits of BAPs measured with MedTech20. STUDY DESIGN: This is a cross-sectional descriptive survey. METHODS: Patients treated in Sweden who had used a BAP for >1 year were mailed the MedTech20 Questionnaire. Responses to each attribute were described, and the MedTech20 Index (0-1), in which a higher figure represents larger benefits from the product, was calculated. Index values were compared based on demographic variables (sex, unilateral or bilateral transfemoral amputation (TFA), and those having experienced any complication of implant parts or the prosthetic connection device). RESULTS: The response rate was 72%. The 62 participants (41 men and 21 women; mean age 57 years) had 11 ± 6.9 mean years of BAP experience. Single attributes stated as highly relevant and with high benefit for BAPs included perceived reliability, perceived safety, sense of control of the disability, facilitation of movement outside home, no discomfort at use, and ease of use. Attributes with less relevance included aid to remember tasks, reduction of barriers to a good sleep, and reduced sense of compromised integrity. The MedTech20 Index was 0.655 ± 0.188 and was not statistically significantly different based on any of the demographic variables. CONCLUSIONS: By using a general measure on attributes of medical devices, this study provides new insights strengthening the evidence regarding the benefits that BAPs provide for patients with TFA who had difficulties with socket-suspended prostheses. Copyright © 2021 International Society for Prosthetics and Orthotics.
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| 24. |
- Hagberg, Kerstin, 1957, et al.
(author)
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Physiological cost index (PCI) and walking performance in individuals with transfemoral prostheses compared to healthy controls
- 2007
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In: Disabil Rehabil. - : Informa UK Limited. - 0963-8288. ; 29:8, s. 643-9
-
Journal article (peer-reviewed)abstract
- PURPOSE: Uncomplicated methods for evaluation of prosthetic walking performance for individuals with lower limb amputations are valuable. The Physiological Cost Index (PCI), the comfortable walking speed (CWS) and self-reported walking distances are three examples of such measures. The aim was to obtain values for these measures for individuals walking with transfemoral prostheses and to compare the results with healthy controls. METHOD: Individuals with an established transfemoral amputation for reasons other than vascular disease (TFA-group, n = 41, 30 male/11 female, mean age 49, SD 11.5) were compared to age-and gender matched healthy controls (Healthy group, n = 22). PCI was assessed walking in CWS for 5 min and self-reported distances accomplished outdoors was assessed with the Walking Habit Score (0 - 100). RESULTS: Mean PCI was 0.55 (SD 0.19) in the TFA-group and 0.31 (SD 0.09) in the Healthy group (p < 0.001). The CWS was 62 (SD 12.6) and 90 (SD 12.8) m/min and the Walking Habit Score 48 (SD 19) and 74 (SD 16) score-points respectively (p < 0.001). CONCLUSIONS: By using uncomplicated and inexpensive methods, this study shows that walking with transfemoral prostheses is done with considerably increased energy cost, slower CWS and that limited walking distances outdoors are performed compared to healthy controls.
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| 25. |
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| 26. |
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| 27. |
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| 28. |
- Hagberg, Kerstin, 1957, et al.
(author)
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Questionnaire for Persons with a Transfemoral Amputation (Q-TFA): Initial validity and reliability of a new outcome measure
- 2004
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In: J Rehabil Res Dev. - 0748-7711. ; 41:5, s. 695-706
-
Journal article (peer-reviewed)abstract
- The Questionnaire for Persons with a Transfemoral Amputation (Q-TFA) is a new self-report measure developed for nonelderly transfemoral amputees using a socket- or osseointegrated prosthesis to reflect use, mobility, problems, and global health, each in a separate score (0-100). This paper describes the initial measurement properties of the Q-TFA as completed by 156 persons with a transfemoral amputation using a socket prosthesis (67% male, 92% nonvascular cases, mean age 51 years). Criterion validity was determined by associations between scores of the Q-TFA and the Short-Form 36 (SF-36)-Item Health Survey. Reliability was assessed by retest (n = 48) and by determination of the internal consistency. Correlations between Q-TFA and SF-36-Item Health Survey scales matched hypothesized patterns. Intraclass correlations were between 0.89 and 0.97, and measurement error ranged from 10 to 19 points. Cronbach's alpha revealed good internal consistency, with no values less than 0.7. This study shows that the Q-TFA, applied to persons using a transfemoral socket prosthesis, has adequate initial validity and reliability.
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| 29. |
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| 30. |
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| 31. |
- Hagberg, Kerstin, 1957, et al.
(author)
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Socket versus bone-anchored trans-femoral prostheses: hip range of motion and sitting comfort
- 2005
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In: Prosthet Orthot Int. - : Ovid Technologies (Wolters Kluwer Health). - 0309-3646. ; 29:2, s. 153-63
-
Journal article (peer-reviewed)abstract
- This is the first study to report on hip range of motion (ROM) among active prosthesis users, when wearing and not wearing a trans-femoral socket prosthesis and to compare with individuals rehabilitated with an osseointegrated bone-anchored prosthesis. In addition, discomfort when sitting with the prosthesis is reported in both groups. The study group all had a non-vascular amputation and were divided into those supplied with a socket prosthesis (S group) (n = 43, mean age 51 years, 74% men) or a bone-anchored prosthesis (OI group) (n = 20, mean age 46 years, 75% men). Active hip ROM was measured with a goniometer, and self-reported problems with discomfort when sitting were recorded. The hip motion decreased in all directions when wearing the socket prosthesis compared to without it (P < 0.001 for all directions), and 37% of the subjects had less than 90 degrees of hip flexion when wearing their prosthesis. Discomfort when sitting was reported among 44% (n = 19) in the S group and was more common among individuals with less than 90 degrees of hip flexion motion (P= 0.025). In the OI group, no restriction in hip motion was measured with the prosthesis, and no subject had less than 90 degrees of flexion and 5% (n = 1) reported discomfort when sitting. This study shows that a trans-femoral prosthetic socket significantly reduces the ROM of the hip and that discomfort when sitting is common among individuals wearing such prostheses. Further, the study confirms that individuals using a bone-anchored prosthesis have no restricted hip motion with the prosthesis and report very few problems with discomfort when sitting.
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| 32. |
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| 33. |
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| 34. |
- Hansson, Elisabeth K, 1954, et al.
(author)
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Patients with unilateral transfemoral amputation treated with a percutaneous osseointegrated prosthesis. A cost-effectiveness analysis
- 2018
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In: Bone and Joint Journal. - 2049-4394. ; 100-B:4, s. 527-534
-
Journal article (peer-reviewed)abstract
- Aims: The aim of this study was to compare the cost-effectiveness of treatment with an osseointegrated percutaneous (OI-) prosthesis and a socket-suspended (S-) prosthesis for patients with a transfemoral amputation. Patients and Methods: A Markov model was developed to estimate the medical costs and changes in quality-adjusted life-years (QALYs) attributable to treatment of unilateral transfemoral amputation over a projected period of 20 years from a healthcare perspective. Data were collected alongside a prospective clinical study of 51 patients followed for two years. Results: OI-prostheses had an incremental cost per QALY gained of €83 374 compared with S-prostheses. The clinical improvement seen with OI-prostheses was reflected in QALYs gained. Results: were most sensitive to the utility value for both treatment arms. The impact of an annual decline in utility values of 1%, 2%, and 3%, for patients with S-prostheses resulted in a cost per QALY gained of €37 020, €24 662, and €18 952, respectively, over 20 years. Conclusion: From a healthcare perspective, treatment with an OI-prosthesis results in improved quality of life at a relatively high cost compared with that for S-prosthesis. When patients treated with S-prostheses had a decline in quality of life over time, the cost per QALY gained by OI-prosthesis treatment was considerably reduced.
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| 35. |
- Hellstrand Tang, Ulla, 1956, et al.
(author)
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Comparison of plantar pressure in three types of insole given to patients with diabetes at risk of developing foot ulcers – A two-year, randomized trial
- 2014
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In: Journal of Clinical and Translational Endocrinology. - : Elsevier BV. - 2214-6237. ; 1:4, s. 121-132
-
Journal article (peer-reviewed)abstract
- Background: Special insoles and shoes designed to prevent foot ulcers caused by repetitive high pressures are recommended for patients with diabetes who have any of the following risk factors: neuropathy; peripheral vascular disease; foot deformities; previous ulcers; amputation; and skin pathologies. However, there is a need for increased knowledge regarding: a) differences in the peak pressure (PP) and pressure time integral (PTI) for different types of insoles; and b) the properties of the pressure distribution for insoles used over a period of several months. We present the results of a randomized trial to compare the plantar pressures of three commonly used insoles. Objectives: The primary objective was to compare the PP and PTI between three types of insoles. The secondary objective was to explore the long-term pattern of peak plantar pressure distribution and variations in specific regions of interest (ROI). The tertiary objective was to investigate the impacts of insole adjustments, how much the insoles were used, and the levels of patient satisfaction. Methods In a 2-year trial, 114 patients with type 1 (N = 31) or type 2 (N = 83) diabetes (62 men and 52 women; mean age, 57.7 ± 15.4 years; duration of diabetes, 12.3 ± 11.2 years; neuropathy, 38%), were randomized to be supplied with one of three different insoles. The ethylene vinyl acetate (EVA) insoles were used in outdoor walking shoes. The 35 EVA group (N = 39) received soft custom-made insoles composed of EVA of 35 shore A hardness, the 55 EVA group (N = 37) received custom-made insoles composed of EVA of 55 shore hardness, and the control group (N = 38) received prefabricated insoles composed of a hard core with a top layer of soft 12 shore hardness microfiber. Using F-Scan®, the in-shoe plantar pressures were measured at seven ROI (hallux, metatarsal head 1, metatarsal head 2, metatarsal head 4, metatarsal head 5, lateral aspect of the mid-foot, heel) on five occasions during the study period. The plantar-pressure variables used were PP (main outcome) and PTI. The plantar patterns of load were explored, satisfaction and usage of the insoles were rated by the participants, and insole adjustments were recorded. Results:A mixed model analysis estimated lower PP values in the heel regions for the 35 EVA and 55 EVA insoles (171 ± 13 and 161 ± 13 kPa, respectively) than for the prefabricated insoles (234 ± 10 kPa) (p
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| 36. |
- Hellstrand Tang, Ulla, 1956, et al.
(author)
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Foot anthropometrics in individuals with diabetes compared with the general Swedish population: Implications for shoe design
- 2017
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In: Foot and Ankle Online Journal. - : International Foot and Ankle Foundation. - 1941-6806. ; 10:3
-
Journal article (peer-reviewed)abstract
- Background: The literature offers sparse information about foot anthropometrics in patients with diabetes related to foot length, foot width and toe height, although these measurements are important in shoe fitting. A poorly fitted shoe is one of many contributory factors in the development of diabetic foot ulcers. The purpose of this study was to describe the foot anthropometrics in groups of patients with diabetes, in groups representing the general population and to explore whether foot anthropometrics differ between patients with diabetes and the general population. Method: Foot anthropometrics (foot length, foot width and maximum toe height) was measured in 164 patients with diabetes, with and without neuropathy (n = 102 and n = 62 respectively). The general population was represented by 855 participants from two sources. Results: Foot length, foot width and toe height varied (220-305 mm; 82-132 mm and 15-45 mm respectively) in the diabetic group and in the group representing the general population (194-306 mm; 74-121 mm and 17-31 mm respectively). Age, gender and BMI influence the foot anthropometrics, however, when adjusting for theses variables the index foot length/width was lower (2.58) in patients with diabetes without neuropathy vs. controls (2.63), p = 0.018. Moreover, patients with diabetes with neuropathy had wider feet (98.6 mm) compared with the controls (97.0 mm), p = 0.047. Conclusions: The individual variations of foot length, foot width and maximum toe height were large. The impact of gender on foot anthropometrics was confirmed and the impact of age and BMI were shown. Patients with diabetes seemed to have a wider forefoot width and a lower foot length to foot width ratio compared to the controls.
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| 37. |
- Hellstrand Tang, Ulla, 1956, et al.
(author)
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Foot deformities, function in the lower extremities, and plantar pressure in patients with diabetes at high risk to develop foot ulcers
- 2015
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In: Diabetic Foot & Ankle. - : Informa UK Limited. - 2000-625X. ; 6
-
Journal article (peer-reviewed)abstract
- Objective : Foot deformities, neuropathy, and dysfunction in the lower extremities are known risk factors that increase plantar peak pressure (PP) and, as a result, the risk of developing foot ulcers in patients with diabetes. However, knowledge about the prevalence of these factors is still limited. The aim of the present study was to describe the prevalence of risk factors observed in patients with diabetes without foot ulcers and to explore possible connections between the risk factors and high plantar pressure. Patients and methods : Patients diagnosed with type 1 ( n= 27) or type 2 ( n= 47) diabetes (mean age 60.0±15.0 years) were included in this cross-sectional study. Assessments included the registration of foot deformities; test of gross function at the hip, knee, and ankle joints; a stratification of the risk of developing foot ulcers according to the Swedish National Diabetes Register; a walking test; and self-reported questionnaires including the SF-36 health survey. In-shoe PP was measured in seven regions of interests on the sole of the foot using F-Scan ® . An exploratory analysis of the association of risk factors with PP was performed. Results : Neuropathy was present in 28 (38%), and 39 (53%) had callosities in the heel region. Low forefoot arch was present in 57 (77%). Gait-related parameters, such as the ability to walk on the forefoot or heel, were normal in all patients. Eighty percent had normal function at the hip and ankle joints. Gait velocity was 1.2±0.2 m/s. All patients were stratified to risk group 3. Hallux valgus and hallux rigidus were associated with an increase in the PP in the medial forefoot. A higher body mass index (BMI) was found to increase the PP at metatarsal heads 4 and 5. Pes planus was associated with a decrease in PP at metatarsal head 1. Neuropathy did not have a high association with PP. Conclusions: This study identified several potential risk factors for the onset of diabetic foot ulcers (DFU). Hallux valgus and hallux rigidus appeared to increase the PP under the medial forefoot and a high BMI appeared to increase the PP under the lateral forefoot. There is a need to construct a simple, valid, and reliable assessment routine to detect potential risk factors for the onset of DFU.
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| 38. |
- Hellstrand Tang, Ulla, 1956, et al.
(author)
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The D-Foot, for prosthetists and orthotists, a new eHealth tool useful in useful in risk classification and foot assessment in diabetes
- 2017
-
In: Foot and Ankle Online Journal. - : International Foot & Ankle Foundation. - 1941-6806. ; 10:2
-
Journal article (peer-reviewed)abstract
- Background: The prevention and care of foot problems in diabetes begins with a risk classification. Today, the prosthetists and orthotists (CPO) and other health care professionals assess the risk of developing foot ulcers more or less subjectively. The objective of the study was to describe the construction of an eHealth tool, the D-Foot, which generates a risk classification. The reliability of the D-Foot was tested. Methods: The D-Foot includes 22 clinical assessments and four self-reported questions. The content validity was assured by expert group consensus and the reliability was assessed through an empirical test-retest study. Inter- and intra-rater reliability was calculated using patients referred to four departments of prosthetics and orthotics (DPO). Results: The agreement for the risk classification generated using the D-Foot was 0.82 (pooled kappa 0.31, varying from 0.16 to 1.00 at single DPOs). The inter-rater agreement was > 0.80 regarding the assessments of amputation, Charcot deformity, foot ulcer, gait deviation, hallux valgus/hallux varus and risk grade. The inter- and intra-rater agreements for the discrete measurements were > 0.59 and > 0.72 respectively. For continuous measurements, the inter- and intra-rater correlation varied (0.33-0.98 and 0.25-0.99 respectively). Conclusion: The D-Foot gave a reliable risk foot classification. However, there was a variation in the inter- and intra-rater reliability of the assessments included and refinements are needed for variables with low agreement. Based on the results, the D-Foot will be revised before it is implemented in clinical practice.
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| 39. |
- Häggström, Eva, et al.
(author)
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Comparison of prosthetic costs and service between osseointegrated and conventional suspended transfemoral prostheses.
- 2013
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In: Prosthetics and orthotics international. - : Ovid Technologies (Wolters Kluwer Health). - 0309-3646. ; 37:2, s. 152-160
-
Journal article (peer-reviewed)abstract
- Background: Nowadays, a transfemoral amputation prosthesis can be fitted to the skeleton using an osseointegrated implant, that is, without a socket. Treated patients have reported improvements in quality of life.Objectives: To investigate differences in prosthetic costs and service of osseointegrated prostheses compared to socket-suspended prostheses.Study Design: Retrospective cost analysis and survey.Methods: Costs and noted visits during in mean ~10 years were taken from one prosthetic workshop and included 50 patients with unilateral transfemoral amputation (36 socket-suspended prostheses, 20 osseointegrated prostheses, 6 patients used both kinds of prostheses). A survey comprised 71 patients (69% males; mean age = 52.3 year; cause: 66% trauma, 23% tumour, 11% other).Results: Statistically significant fewer workshop visits were shown with osseointegrated prostheses compared to socket-suspended prostheses (cost analysis: 3.1 vs. 7.2 visits/year, survey: 3.4 vs. 9.2 visits/year). The mean total annual cost of new prostheses, services, repairs and adjustments was 14% lower for osseointegrated prostheses than socket-suspended prostheses (€3149 and €3672 respectively, p = 0.632). A subgroup analysis of recent produced prostheses revealed cost of material to account for 92.5% for osseointegrated prostheses and 70% for socket-suspended prostheses.Conclusion: Despite significantly fewer visits for prosthetic service the annual mean costs for osseointegrated prostheses were comparable with socket-suspended prostheses. This study suggests it is due to more advanced prosthetic components being used with osseointegrated prostheses.
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| 40. |
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| 41. |
- Häggström, Eva, et al.
(author)
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Vibrotactile evaluation: Osseointegrated versus socket-suspended transfemoral prostheses
- 2013
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In: Journal of Rehabilitation Research and Development. - : Journal of Rehabilitation Research & Development. - 0748-7711 .- 1938-1352. ; 50:10, s. 1423-1434
-
Journal article (peer-reviewed)abstract
- This study investigated detection thresholds of vibrometric stimuli in patients with transfemoral amputation supplied with osseointegrated (OI) and socket-suspended prostheses. It included 17 patients tested preoperatively with socket-suspended prostheses and after 2 yr with OI prostheses and a control group (n = 17) using socket-suspended prostheses, evaluated once. Assessments on the prosthetic and intact feet were conducted at six frequencies (8, 16, 32, 64, 125, and 250 Hz). Furthermore, measurements were conducted to investigate how vibrometric signals are transmitted through a test prosthesis. The results showed that the OI group had improved ability to detect vibrations through the prosthesis at 125 Hz (p = 0.01) at follow-up compared with the preoperative measurement. Compared with the control group, the 01 group at follow-up had better ability to detect high frequency vibrations through the prosthesis (125 Hz, p = 0.02; 250 Hz, p = 0.03). The vibrometric signal transmitted through the test prosthesis was reduced at 8, 125, and 250 Hz but was amplified at 16, 32, and 64 Hz. Differences between the OI and the control groups were found in the highest frequencies in which the test prosthesis showed reduction of the vibrometric signal. The study provides insight into the mechanisms of vibration transmission between the exterior and bone-anchored as well as socket-suspended amputation prostheses.
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| 42. |
- Kohler, Friedbert, et al.
(author)
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Categorization and recommendations for outcome measures for lower limb absence by an expert panel
- 2023
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In: Prosthetics and Orthotics International. - 0309-3646 .- 1746-1553. ; 47:6, s. 565-574
-
Journal article (peer-reviewed)abstract
- Background: Understanding the psychometric strengths and limitations of outcome measures for use with people with lower limb absence (LLA) is important for selecting measures suited to evaluating patient outcomes, answering clinical and research questions, and informing health care policy. The aim of this project was to review the current psychometric evidence on outcome measures in people with LLA to determine which measures should be included in a stakeholder consensus process. Methods: An expert panel was assembled, and a 3-stage review process was used to categorize outcome measures identified in a systematic literature review into 3 distinct categories (recommended for measures with better than adequate psychometric properties; recommended with qualification; and unable to recommend). Panelists were asked to individually categorize measures based on results of a systematic review of identified measures’ psychometric properties. Each measure’s final categorization was based on $70% agreement by all panelists. Results: No outcome measure attained the $70% consensus threshold needed to achieve a rating of “recommend.” Hence, panelists suggested combining “recommend” and “recommend with qualifications” into a single category of “recommend with qualifications.” Using this approach, consensus was reached for 59 of 60 measures. Consensus could not be reached on 1 outcome measure (socket comfort score). Thirty-six outcome measures were categorized as “unable to recommend” based on available evidence; however, 23 (12 patient-reported measures and 11 performance-based measures) demonstrated adequate psychometric properties in LLA samples and were thus rated as “recommend with qualification” by the expert panel. The panel of experts were able to recommend 23 measures for inclusion in the subsequent stakeholder review. A key strength of this process was bringing together international researchers with extensive experience in developing and/or using LLA outcome measures who could assist in identifying psychometrically sound measures to include in a subsequent stakeholder consensus process. Conclusion: The above categorizations represent the current state of psychometric evidence on outcome measures for people with LLA and hence may change over time as additional research becomes available. The results will be used to achieve wider consensus from clinicians, health policymakers, health clinic managers, researchers, and end users (i.e., individuals with LLA) on outcome measures for the International Society of Prosthetics and Orthotics lower limb Consensus Outcome Measures for Prosthetic and Amputation ServiceS.
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| 43. |
- Kuhlmann, A., et al.
(author)
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The Kenevo microprocessor-controlled prosthetic knee compared with non-microprocessor-controlled knees in individuals older than 65 years in Sweden : A cost-effectiveness and budget-impact analysis
- 2022
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In: Prosthetics and Orthotics International. - : Wolters Kluwer. - 0309-3646 .- 1746-1553. ; 46:5, s. 414-424
-
Journal article (peer-reviewed)abstract
- BACKGROUND: Growing evidence suggests that individuals with transfemoral amputation or knee disarticulation using a prosthesis equipped with a microprocessor-controlled knee (MPK) benefit from enhanced mobility and safety, including less falls. In elderly individuals, high mortality rates are assumed to reduce the expected useful life of MPKs, and this raises concerns regarding their economic effectiveness. OBJECTIVE: To investigate the cost-effectiveness and budget impact of the Kenevo/MPK (Ottobock, Germany) compared with non-microprocessor-controlled knees (NMPKs) in people older than 65 years at the time of transfemoral amputation/knee disarticulation, from a Swedish payer's perspective. METHODS: A decision-analytic model was developed to conduct the economic analysis of the Kenevo/MPK. Model parameters were derived from Swedish databases and published literature. Univariate and probabilistic sensitivity analyses were performed to explore parameter uncertainty. RESULTS: Compared with NMPKs, the Kenevo/MPK reduced the frequency of hospitalizations by 137 per 1,000 person years while the frequency of fatal falls was reduced by 19 per 1,000 person-years in the simulation. Over a 25-year time horizon, the incremental cost-effectiveness ratio was EUR11,369 per quality-adjusted life year. The probability of the MPK being cost-effective at a threshold of EUR40,000 per quality-adjusted life year was 99%. The 5-year budget impact model predicted an increase in payer expenditure of EUR1.76 million if all new patients received a Kenevo/MPK, and 50% of current NMPK users switched to the MPK. CONCLUSIONS: Results of the modeling suggest that the Kenevo/MPK is likely to be cost-effective for elderly individuals, primarily because of a reduction in falls.
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| 44. |
- Lee, W. C., et al.
(author)
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Kinetics of transfemoral amputees with osseointegrated fixation performing common activities of daily living
- 2007
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In: Clin Biomech (Bristol, Avon). - : Elsevier BV. - 0268-0033. ; 22:6, s. 665-73
-
Journal article (peer-reviewed)abstract
- BACKGROUND: Direct anchorage of a lower-limb prosthesis to the bone through an implanted fixation (osseointegration) has been suggested as an excellent alternative for amputees experiencing complications from use of a conventional socket-type prosthesis. However, an attempt needs to be made to optimize the mechanical design of the fixation and refine the rehabilitation program. Understanding the load applied on the fixation is a crucial step towards this goal. METHODS: The load applied on the osseointegrated fixation of nine transfemoral amputees was measured using a load transducer, when the amputees performed activities which included straight-line level walking, ascending and descending stairs and a ramp as well as walking around a circle. Force and moment patterns along each gait cycle, magnitudes and time of occurrence of the local extrema of the load, as well as impulses were analysed. FINDINGS: Managing a ramp and stairs, and walking around a circle did not produce a significant increase (P>0.05) in load compared to straight-line level walking. The patterns of the moment about the medio-lateral axis were different among the six activities which may reflect the different strategies used in controlling the prosthetic knee joint. INTERPRETATIONS: This study increases the understanding of biomechanics of bone-anchored osseointegrated prostheses. The loading data provided will be useful in designing the osseointegrated fixation to increase the fatigue life and to refine the rehabilitation protocol.
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| 45. |
- Lundberg, Mari, 1969, et al.
(author)
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My prosthesis as part of me : qualitative analysis of living with an osseointegrated prosthetic limb
- 2011
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In: Prosthetics and Orthotics International. - : Ovid Technologies (Wolters Kluwer Health). - 0309-3646 .- 1746-1553. ; 35:2, s. 207-214
-
Journal article (peer-reviewed)abstract
- Background:Bone-anchored prosthesis is still a rather unusual treatment for patients with limb loss.Objectives: The aim of this study was to improve our understanding about the experience of living with an osseointegrated prosthesis (OI-prosthesis) compared to one suspended with a socket, through the use of qualitative research methodology.Study design: A qualitative phenomenological research method.Methods: Thirteen Swedish patients (37–67 years) with unilateral upper or lower limb amputation (10 transfemoral, 2 transhumeral, 1 transradial), who had been using OI-prostheses for 3 to 15 years, were recruited by means of purposive sampling. An audio-taped in-depth interview was performed. The guiding question was ‘How do you experience living with your osseointegrated prosthesis compared to your earlier prostheses suspended with sockets?’. The empirical phenomenological psychological method was used for data analysis.Results: The results showed that all participants described living with an OI-prosthesis as a revolutionary change. These experiences were described in terms of three typologies, called ‘Practical prosthesis’, ‘Pretend limb’ and ‘A part of me’.Conclusions: The most important finding was that the change went beyond the functional improvements, integrating the existential implications in the concept of quality of life.Clinical relevance: This qualitative in-depth interview study on patients using bone-anchored prosthetic limbs showed that all described a revolutionary change in their lives as amputees and the meaning of that change went beyond the functional improvements, integrating existential implications in the concept of quality of life.
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| 46. |
- Möller, Saffran, et al.
(author)
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Cortical brain activity in transfemoral or knee-disarticulation prosthesis users performing single- and dual-task walking activities
- 2020
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In: Journal of Rehabilitation and Assistive Technologies Engineering. - : SAGE Publications. - 2055-6683. ; 7
-
Journal article (peer-reviewed)abstract
- Introduction: Walking with a prosthesis while performing secondary tasks increases demand on cognitive resources, compromising balance and gait. This study investigated effects of a secondary task on patterns of brain activity and temporospatial gait parameters in individuals using a prosthesis with or without a microprocessor-controlled prosthetic knee(MPK) and controls. Methods: A cross-sectional study with repeated measures was performed. Twenty-nine individuals with amputations and 16 controls were recruited. Functional near-infrared spectroscopy was used to evaluate changes in oxygenated and de-oxygenated haemoglobin in the prefrontal cortex and temporospatial variables during single-and dual-task walking. Results: Differences in brain activity were observed within the MPK-group and controls without changes in temporospatial parameters. The Trail-Walking test was associated with highest levels of brain activity in both groups. No differences were observed between single- and dual-task walking in the non-MPK-group (p > 0.05). The Non-MPK and the MPK-group recorded higher levels of brain activity than controls during single-task walking and poorer results on temporospatial variables compared to controls. Conclusions: For the MPK-group and controls, introduction of a secondary task led to an increase in brain activity. This was not seen in the Non-MPK-group. Significant differences in brain activity were observed in the absence of changes in temporospatial parameters.
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| 47. |
- Möller, Saffran, et al.
(author)
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Perceived self-efficacy and specific self-reported outcomes in persons with lower-limb amputation using a non-microprocessor-controlled versus a microprocessor-controlled prosthetic knee
- 2018
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In: Disability and Rehabilitation-Assistive Technology. - : Informa UK Limited. - 1748-3107 .- 1748-3115. ; 13:3, s. 220-225
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Journal article (peer-reviewed)abstract
- Purpose: To measure self-efficacy in a group of individuals who have undergone a lower-limb amputation and investigate the relationship between self-efficacy and prosthetic-specific outcomes including prosthetic use, mobility, amputation-related problems and global health. A second purpose was to examine if differences exist in outcomes based upon the type of prosthetic knee unit being used. Method: Cross-sectional study using the General Self-Efficacy (GSE) Scale and the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA). Forty-two individuals participated in the study. Twenty-three used a non-microprocessor-controlled prosthetic knee joint (non-MPK) and 19 used a microprocessor-controlled prosthetic knee joint (MPK). Results: The study sample had quite high GSE scores (32/40). GSE scores were significantly correlated to the Q-TFA prosthetic use, mobility and problem scores. High GSE scores were related to higher levels of prosthetic use, mobility, global scores and negatively related to problem score. No significant difference was observed between individuals using a non-MPK versus MPK joints. Conclusions: Individuals with high self-efficacy used their prosthesis to a higher degree and high self-efficacy was related to higher level of mobility, global scores and fewer problems related to the amputation in individuals who have undergone a lower-limb amputation and were using a non-MPK or MPK knee.
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| 48. |
- Möller, Saffran, et al.
(author)
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Reduced cortical brain activity with the use of microprocessor-controlled prosthetic knees during walking
- 2019
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In: Prosthetics and Orthotics International. - : Sage Publications. - 0309-3646 .- 1746-1553. ; 43:3, s. 257-265
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Journal article (peer-reviewed)abstract
- Background: Individuals using a lower-limb prosthesis indicate that they need to concentrate on every step they take. Despite self-reports of increased cognitive demand, there is limited understanding of the link between cognitive processes and walking when using a lower-limb prosthesis.Objective: The objective was to assess cortical brain activity during level walking in individuals using different prosthetic knee components and compare them to healthy controls. It was hypothesized that the least activity would be observed in the healthy control group, followed by individuals using a microprocessor-controlled prosthetic knee and finally individuals using a non-microprocessor-controlled prosthetic knee.Study Design: Cross-sectional study.Methods:: An optical brain imaging system was used to measure relative changes in concentration of oxygenated and de-oxygenated haemoglobin in the frontal and motor cortices during level walking. The number of steps and time to walk 10 m was also recorded. The 6-min walk test was assessed as a measure of functional capacity.Results: Individuals with a transfemoral or knee-disarticulation amputation, using non-microprocessor-controlled prosthetic knee ( n = 14) or microprocessor-controlled prosthetic knee ( n = 15) joints and healthy controls ( n = 16) participated in the study. A significant increase was observed in cortical brain activity of individuals walking with a non-microprocessor-controlled prosthetic knee when compared to healthy controls ( p < 0.05) and individuals walking with an microprocessor-controlled prosthetic knee joint ( p < 0.05).Conclusion: Individuals walking with a non-microprocessor-controlled prosthetic knee demonstrated an increase in cortical brain activity compared to healthy individuals. Use of a microprocessor-controlled prosthetic knee was associated with less cortical brain activity than use of a non-microprocessor-controlled prosthetic knee.Clinical Relevance: Increased understanding of cognitive processes underlying walking when using different types of prosthetic knees can help to optimize selection of prosthetic components and provide an opportunity to enhance functioning with a prosthesis.
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| 49. |
- Rusaw, David, et al.
(author)
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Bilateral electromyogram response latency following platform perturbation in unilateral transtibial prosthesis users: Influence of weight distribution and limb position
- 2013
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In: Journal of Rehabilitation Research and Development. - : Journal of Rehabilitation Research & Development. - 0748-7711 .- 1938-1352. ; 50:4, s. 531-544
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Journal article (peer-reviewed)abstract
- Appropriate muscular response following an external perturbation is essential in preventing falls. Transtibial prosthesis users lack a foot-ankle complex and associated sensorimotor structures on the side with the prosthesis. The effect of this lack on rapid responses of the lower limb to external surface perturbations is unknown. The aim of the present study was to compare electromyogram (EMG) response latencies of otherwise healthy, unilateral, transtibial prosthesis users (n = 23, mean +/- standard deviation [SD] age =48 +/- 14 yr) and a matched control group (n = 23, mean +/- SD age = 48 +/- 113 yr) following sudden support-surface rotations in the pitch plane (toes-up and toes-down). Perturbations were elicited in various weight-bearing and limb-perturbed conditions. The results indicated that transtibial prosthesis users have delayed responses of multiple muscles of the lower limb following perturbation, both in the intact and residual limbs. Weight-bearing had no influence on the response latency in the residual limb, but did on the intact limb Which limb received the perturbation was found to influence the muscular response, with the intact limb showing a significantly delayed response when the perturbation was received only on the side with a prosthesis. These delayed responses may represent an increased risk of falling for individuals who use transtibial prostheses.
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| 50. |
- Rusaw, David, et al.
(author)
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Can vibratory feedback be used to improve postural stability in persons with transtibial limb loss?
- 2012
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In: Journal of rehabilitation research and development. - 1938-1352 .- 0748-7711. ; 49:8, s. 1239-54
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Journal article (peer-reviewed)abstract
- The use of vibration as a feedback modality to convey motion of the body has been shown to improve measures of postural stability in some groups of patients. Because individuals using transtibial prostheses lack sensation distal to the amputation, vibratory feedback could possibly be used to improve their postural stability. The current investigation provided transtibial prosthesis users (n = 24, mean age 48 yr) with vibratory feedback proportional to the signal received from force transducers located under the prosthetic foot. Postural stability was evaluated by measuring center of pressure (CoP) movement, limits of stability, and rhythmic weight shift while participants stood on a force platform capable of rotations in the pitch plane (toes up/toes down). The results showed that the vibratory feedback increased the mediolateral displacement amplitude of CoP in standing balance and reduced the response time to rapid voluntary movements of the center of gravity. The results suggest that the use of vibratory feedback in an experimental setting leads to improvements in fast open-loop mechanisms of postural control in transtibial prosthesis users.
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