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- Berg, Svante, 1953-
(författare)
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On Total Disc Replacement
- 2010
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Low back pain consumes a large part of the community’s resources dedicated to health care and sick leave. Back disorders also negatively affect the individual leading to pain suffering, decreased quality-of-life and disability. Chronic low back pain (CLBP) due to degenerative disc disease (DDD) is today often treated with fusion when conservative treatment has failed and symptoms are severe. This treatment is as successful as arthroplasty is for hip arthritis in restoring the patient’s quality of life and reducing disability. Even so, there are some problems with this treatment, one of these being recurrent CLBP from an adjacent segment (ASD) after primarily successful surgery. This has led to the development of alternative surgical treatments and devices that maintain or restore mobility, in order to reduce the risk for ASD. Of these new devices, the most frequently used are the disc prostheses used in Total Disc Replacement (TDR).This thesis is based on four studies comparing total disc replacement with posterior fusion. The studies are all based on a material of 152 patients with DDD in one or two segments, aged 20-55 years that were randomly treated with either posterior fusion or TDR.The first study concerned clinical outcome and complications. Follow-up was 100% at both one and two years. It revealed that both treatment groups had a clear benefit from treatment and that patients with TDR were better in almost all outcome scores at one-year follow-up. Fusion patients continued to improve during the second year. At two-year follow-up there was a remaining difference in favour of TDR for back pain. 73% in the TDR group and 63% in the fusion group were much better or totally pain-free (n.s.), while twice as many patients in the TDR group were totally pain free (30%) compared to the fusion group (15%).Time of surgery and total time in hospital were shorter in the TDR group.There was no difference in complications and reoperations, except that seventeen of the patients in the fusion group were re-operated for removal of their implants.The second study concerned sex life and sexual function. TDR is performed via an anterior approach, an approach that has been used for a long time for various procedures on the lumbar spine. A frequent complication reported in males when this approach is used is persistent retrograde ejaculation. The TDR group in this material was operated via an extra-peritoneal approach to the retroperitoneal space, and there were no cases of persistent retrograde ejaculation. There was a surprisingly high frequency of men in the fusion group reporting deterioration in ability to have an orgasm postoperatively.Preoperative sex life was severely hampered in the majority of patients in the entire material, but sex life underwent a marked improvement in both treatment groups by the two-year follow-up that correlated with reduction in back pain.The third study was on mobility in the lumbar spinal segments, where X-rays were taken in full extension and flexion prior to surgery and at two-year follow-up. Analysis of the films showed that 78% of the patients in the fusion group reached the surgical goal (non-mobility) and that 89% of the TDR patients maintained mobility.Preoperative disc height was lower than in a normative database in both groups, and remained lower in the fusion group, while it became higher in the TDR group. Mobility in the operated segment increased in the TDR group postoperatively. Mobility at the rest of the lumbar spine increased in both treatment groups. Mobility in adjacent segments was within the norm postoperatively, but slightly larger in the fusion group.In the fourth study the health economics of TDR vs Fusion was analysed. The hospital costs for the procedure were higher for patients in the fusion group compared to the TDR group, and the TDR patients were on sick-leave two months less.In all, these studies showed that the results in the TDR group were as good as in the fusion group. Patients are more likely to be totally pain-free when treated with TDR compared to fusion. Treatment with this new procedure seems justified in selected patients at least in the short-term perspective. Long-term follow-up is underway and results will be published in due course.
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| 2. |
- Henriques, Thomas, 1957-
(författare)
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Biomechanical and Clinical Aspects on Fixation Techniques in the Cervical Spine
- 2003
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- The present work is analyzing the general biomechanical aspects of fixation techniques in the upper and lower cervical spine along with clinical implications.The in vitro biomechanical properties of five different posterior atlanto-axial fixation techniques are compared. They provided for either a one, two or three-point fixation between atlas and axes. A new device, the C1 claw was biomechanically tested, which allow for fixation without the need for a structural bone graft. The three-point reconstructions indicated superior biomechanical properties compared to all others.The new C1 claw device was clinically evaluated in a series of 26 patients treated with a posterior C1-C2 fusion. There were no clinical or radiological failures in the series, Twenty-one patients out of twenty-three with any length of follow up either showed a solidly healed fusion or a healed fracture. Distractive flexion (DF) injuries in the lower cervical spine treated with anterior plate alone were analyzed with respect to healing rate and complications in a consecutive series of 36 patients. Results indicated that DF injury stage 1 and 2 according to Allen and Ferguson healed without complication, whereas DF injuries stage 3 had a high frequency of failure, needing an additional posterior fixation. The in vitro biomechanical properties of four different fixation techniques for a distractive flexion injury stage 3 were analyzed. The result indicated that anterior plate alone for fixation of a DF injury stage 3 is insufficient supporting the clinical finding in the previous study.Adjacent level motion was analyzed following a one segment fusion in the lower cervical spine. Motion was found to increase in adjacent levels possibly contributing to accelerated degeneration.
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| 3. |
- MacDowall, Anna, 1976-
(författare)
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Cervical Radiculopathy : Studies on Pain Analysis and Treatment
- 2018
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Background: Knowledge about how to interpret pain-analyzing tools such as the pain drawing test and the visual analog scale (VAS) in cervical spine patients are sparse; hence, they have never been validated for this subgroup of patients. The method of artificial disc replacement (ADR) has been developed as an alternative treatment to fusion surgery after decompression for cervical degenerative disc disease (DDD) with radiculopathy. Preserved motion of ADR devices aims to prevent immobilization side effects such as stiffness, dysphagia and adjacent segment pathology. Long-term follow-ups of these devices compared with the gold standard treatment are needed to create future guidelines.Objectives: This thesis aims at (1) validating the pain drawing as an investigational tool for the cervical spine, (2) validating the VAS for the cervical spine regarding the measurement noise and the minimum clinically important difference (MCID), (3) comparing ADR with fusion surgery at 5-years of follow-up regarding outcome and complications in a randomized controlled trial (RCT) as well as in the Swedish spine (Swespine) registry, and (4) investigating possible predictors to outcome after surgical treatment of cervical radiculopathy.Methods: An RCT with 153 patients undergoing surgery for cervical radiculopathy was performed. Baseline data, the Neck disability index (NDI), two sets of VAS-neck and VAS-arm scores, the EQ-5D, Hospital anxiety and depression scale (HADS), Dysphagia short questionnaire and a pain drawing test were gathered preoperatively and after 5 years. Radiographs in flexion/extension and MRIs were done preoperatively and at follow-up. All patients registered in Swespine since January 1st, 2006 with cervical DDD and radiculopathy treated with ADR or fusion surgery, were included. Baseline data, the NDI, EQ-5D, and VAS-neck and VAS-arm scores were analyzed at 1, 2, 5 and 10-years of follow-up as well as the information regarding secondary surgeries.Results: Pain drawings interpreted with the simple body region method showed good inter-rater reliability in cervical spine patients. Markings in the upper arm region on the pain drawing predicted surgical treatment outcome and markings in the head region predicted depression. The measurement noise was ~10 mm and the MCID was ~20 mm on a 100 mm pain VAS. In both the RCT and Swespine register the outcome after ADR surgery were comparable with fusion at 5 years of follow-up, except for an elevated risk regarding secondary surgery on the index level in the ADR group. Fifty percent of the patients in the RCT, allocated to ADR surgery had preserved motion of less than 5°, at the 5-year follow-up, and 25%, mostly men were spontaneously fused. Preserved motion did not prevent adjacent segment pathology. High values of preoperative HADS scores were negative predictors of outcome.Conclusions: In patients with cervical DDD and radiculopathy both the pain drawing test and the VAS are validated tools to interpret the patients’ pain. Preoperative mental distress affects long-term outcome much more than the allocated treatment, ADR or fusion surgery in patients with cervical radiculopathy.Clinical Trial Registration: ISRCTN, registration number: 44347115.
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| 4. |
- Marques, Catarina, 1969-
(författare)
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Studies on Cervical Artificial Disc Replacement
- 2022
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Artificial disc replacement (ADR) was developed as an alternative to anterior fusion after decompression for cervical degenerative radiculopathy. By preserving motion, it was expected to prevent acceleration of adjacent segment pathology (ASP) associated with fusion, and lead to better clinical outcomes. The aims of this thesis were to evaluate whether ADR surgery leads to better outcomes than fusion surgery, to investigate if it prevents the acceleration of ASP, and to analyze its potential complications. In a multicenter randomized controlled trial (RCT) 153 patients were randomized to ADR (DiscoverTM implant) or fusion surgery (autograft, plate and screws). The outcomes at 5 and 10 years postoperatively were analyzed with Neck Disability Index (NDI) as primary measure. Heterotopic ossification (HO), ASP, and secondary surgery where analyzed. The measurements of radiographic parameters used in the assessment of cervical alignment where validated.To further analyze secondary surgery after ADR, a descriptive register cohort study was done with 42 patients whose data were retrieved from Swespine and completed with medical charts, images, and a telephone interview. There was no difference in NDI scores between groups in the RCT, 5 or 10 years postoperatively. Radiological and clinically significant ASP were similar in both groups. There was more secondary surgery in the ADR group compared with the fusion group, mainly due to device loosening in women. Severe HO was seen in 71% of the ADR implants 5 years postoperatively, and 27% were fused, male sex being a clear risk factor.Normative data for measurement error were provided on the cervical alignment measurements, and the most reliable were the K-line tilt and the cervical sagittal vertical axis (cSVA). In the 42 patients in the register cohort study the most common diagnosis leading to reoperation was loosening of the ADR implant and/or ASP, predominantly treated with fusion surgery. Reoperation resulted in good outcomes in the vast majority of patients. At the long-term, there is no clinical benefit of ADR over fusion surgery after decompression for cervical degenerative radiculopathy. ADR, compared with fusion surgery, does not prevent acceleration of ASP, and results in more reoperations. Revision surgery for failed cervical ADRs is effective and justified.
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| 5. |
- Marques, Catarina, 1969-, et al.
(författare)
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The fate of failed cervical arthroplasties: outcome of revision surgery
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- Purpose: To analyze the diagnoses leading to secondary surgery, the surgical methods used in reoperations, and the final clinical outcomes, in patients reoperated after a primary reconstruction with a cervical artificial disc replacement (ADR). Methods: Descriptive cohort study of 42 ADR patients who underwent secondary surgery at the index or adjacent level. Data collected from the National Swedish Register for Spine Surgery 2006 through 2018, completed with information from patients’ charts, images, and a telephone interview with the patients. Analysis of time to reoperation, diagnosis leading to reoperation, surgical method, and outcome at 2 years, measured as change in neck pain, arm pain and function, as well as overall patient satisfaction. Results: The most common diagnosis leading to reoperation was loosening (n=16), clinical adjacent segment pathology (ASP) (n=8), or a combination thereof (n=6). Thirty-four of the surgeries were performed at the index level. Mean time to reoperation was 44 months.Reoperation consisted of extraction of the ADR and fusion surgery in 32 cases. Function improved after the reoperation in 32 patients. Twenty-four of 30 patients who had neck pain, and 28 of 32 who had arm pain improved after the reoperation. No patients reported post-operative aggravation of symptoms.Conclusion: Failure of ADR is mainly due to loosening of the implant and/or ASP, and is predominantly treated with fusion surgery. Reoperation results in good outcomes (complete or nearly complete recovery) in the vast majority of patients. We conclude that revision surgery for failed cervical arthroplasty is effective and justified.
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| 7. |
- Robinson, Anna-Lena, 1971-
(författare)
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Axis Fractures in Elderly : Epidemiology and Treatment related outcome
- 2018
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Background: Axis fractures are a common injury in the elderly population. Treatment is often complicated due to osteoporosis and patient comorbidity. Knowledge of the incidence of these fractures, as well as their treatment, outcome and mortality rate, will improve knowledge and decision-making processes for this fragile group of patients.Objectives: This thesis aims (1) to review the literature on the non-surgical and surgical treatment of odontoid fractures type 2 in the elderly population, (2) to provide an updated overview of axis fracture subtypes, their incidence and their treatment in a cohort in two university cities, (3) to map the incidence of fractures and the treatment of these patients in Sweden, (4) to investigate the effect on mortality of both the surgical and non-surgical treatment of axis fractures and (5) to present the protocol for a randomized controlled trial (RCT) on the treatment of odontoid fractures type 2 in the elderly population.Methods: A systematic review was performed using the MeSH keywords “odontoid AND fracture AND elderly”. The data for the cohort study were extracted from the regional hospital information system. The radiographs were reviewed retrospectively. Data were extracted from the Swedish National Patient Registry (NPR) and the mortality registry for the national registry studies. Finally, the RCT protocol was carried out according to the SPIRIT and CONSORT statements for clinical trial reporting.Results and conclusions: So far, there has been a scarcity of existing evidence on treatment of odontoid fractures type 2 in the elderly population. In this thesis, we found in two university cities an increased incidence, and a trend towards more surgical treatment of type 2 and 3 odontoid fractures 2002-2014. Between 1997 and 2014 in Sweden, there was an increasing incidence of C2 fractures, but the treatment trend went towards more non-surgical treatment. Surgically treated patients had a greater survival rate than non-surgically treated patients. Among those over 88 years of age, surgical treatment lost its effect on survival. In the RCT we will study the function of patients with odontoid fractures type 2 and by comparing non-surgical treatment with posterior C1-C2 fusion, the cost-effectiveness of the treatment options.
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| 8. |
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| 9. |
- Robinson, Yohan, 1977-, et al.
(författare)
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Biological disease-modifying anti-rheumatic treatment delayed spinal fractures related to ankylosing spondylitis : National multi-registry cohort study from the Swedish Patient Registry and the Swedish Prescribed Drugs Registry
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- ObjectiveAnkylosing spondylitis (AS) is associated with increased spinal fracture risk due to loss of elasticity in spinal motion segments. With the introduction of biological disease modifying anti-rheumatic drugs (bDMARD) treatment for AS patients the individual course of the disease has been decelerated. This study aims to clarify whether the improved medical therapy reduced the spinal fracture incidence.MethodsIncluded were all patients with the diagnosis of AS 1987 to 2014 from the Swedish Patient Registry. From the Swedish Prescribed Drug Registry the Anatomical Therapeutic Chemical codes for bDMARD, non-steroidal anti-inflammatory drugs (NSAID), methotrexate (MTX) and sulfasalazine were extracted and numbers of prescriptions and years of treatment counted since 2005.Results 12297 patients with ankylosing spondylitis were included between 1987 and 2014 (age 67±19, 67% male). Of these 291 had spinal fractures between 2011 and 2014. The number of prescriptions of bDMARD increased during the last decade, but not of MTX, sulfasalazine and NSAID. 64% of all AS patients used NSAID, 13% used bDMARD, 13% used MTX, and 10% used sulfasalazine. A multivariate analysis of patients with spinal fractures 2011-2014 found bDMARD delaying spinal fracture debut by 1.24 years per year of bDMARD treatment (p=0.028). The use of bDMARD had no significant effect on spinal fracture risk (OR=0.93, 95%-C.I.=0.85-1.01, p=0.09).ConclusionThis study failed to demonstrate a beneficial effect on spinal fracture risk for AS patients treated with bDMARD during the last decade. Still bDMARD treatment delayed spinal fracture occurrence, which is promising with regard to results from future studies.Trial registrationClinicalTrials.gov, Identifier NCT02840695.
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| 10. |
- Robinson, Yohan, 1977-
(författare)
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Spinal fractures related to ankylosing spondylitis : Epidemiology, clinical outcome and biomechanics
- 2017
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Background: Spinal fractures related to ankylosing spondylitis (AS) are often associated with serious complications. Therefore, knowledge of the incidence, best treatment, outcome, and prevention would assist in improving current guidelines.Objectives: This thesis aims at (1) analysing the complications and mortality of surgical treatment, (2) mapping the incidence and treatment modalities for these patients in Sweden, as well as (3) investigating the putative preventive effect of biological disease modifying anti-rheumatic drug (bDMARD) therapy on spinal fractures related to AS.Methods: Merged multiple national registries were used to identify predictors of mortality and spinal fractures in patients with AS. Beyond that a finite element model (FEM) was designed to simulating a cervicothoracic fracture related to AS.Results and Conclusions: During the last two decades an increase of the incidence of vertebral fractures in patients with AS was observed. With the introduction of bDMARD treatment of AS was revolutionised and quality of life and function improved. It seems that the improved quality of life and function in these patients does not correlate with a reduced fracture risk. Still, for the first time a beneficial effect of bDMARD with regard to spinal fracture occurrence was provided. The risk of spinal fractures was not reduced, but the debut of a spinal fracture was delayed with bDMARD. Since for this study the observation interval was only a decade, a future follow-up should revisit the effect of bDMARD on spinal fractures related to AS.Furthermore, it was shown that posterior stabilisation is an effective method for restoring stability without the necessity of additional external fixation. Most likely the early rehabilitation reduced pulmonary complications, which in turn reduced early mortality of these fractures. The FEM could be used to identify the most appropriate implant configuration, since no well-established cadaver models exist.Clinical Trial Registration: ClinicalTrials.gov, Identifier NCT02840695.
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