| 51. |
- Engquist, Markus, et al.
(författare)
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Factors Affecting the Outcome of Surgical Versus Nonsurgical Treatment of Cervical Radiculopathy
- 2015
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Ingår i: Spine. - : LIPPINCOTT WILLIAMS & WILKINS. - 0362-2436 .- 1528-1159. ; 40:20, s. 1553-1563
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Tidskriftsartikel (refereegranskat)abstract
- Study Design. Prospective randomized controlled trial. Objective. To analyze factors that may influence the outcome of anterior cervical decompression and fusion (ACDF) followed by physiotherapy versus physiotherapy alone for treatment of patients with cervical radiculopathy. Summary of Background Data. An understanding of patient-related factors affecting the outcome of ACDF is important for preoperative patient selection. No previous prospective, randomized study of treatment effect modifiers relating to outcome of ACDF compared with physiotherapy has been carried out. Methods. 60 patients with cervical radiculopathy were randomized to ACDF followed by physiotherapy or physiotherapy alone. Data for possible modifiers of treatment outcome at 1 year, such as sex, age, duration of pain, pain intensity, disability (Neck Disability Index, NDI), patient expectations of treatment, anxiety due to neck/arm pain, distress (Distress and Risk Assessment Method), self-efficacy (Self-Efficacy Scale) health status (EQ-5D), and magnetic resonance imaging findings were collected. A multivariate analysis was performed to find treatment effect modifiers affecting the outcome regarding arm/neck pain intensity and NDI. Results. Factors that significantly altered the treatment effect between treatment groups in favor of surgery were: duration of neck pain less than 12 months (P = 0.007), duration of arm pain less than 12 months (P = 0.01) and female sex (P = 0.007) (outcome: arm pain), low EQ-5D index (outcome: neck pain, P = 0.02), high levels of anxiety due to neck/arm pain (outcome: neck pain, P = 0.02 and NDI, P = 0.02), low Self-Efficacy Scale score (P = 0.05), and high Distress and Risk Assessment Method score (P = 0.04) (outcome: NDI). No factors were found to be associated with better outcome with physiotherapy alone. Conclusion. In this prospective, randomized study of patients with cervical radiculopathy, short duration of pain, female sex, low health quality, high levels of anxiety due to neck/arm pain, low self-efficacy, and a high level of distress before treatment were associated with better outcome from surgery. No factors were found to be associated with better outcome from physiotherapy alone.
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| 52. |
- Flam, B, et al.
(författare)
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Authors' Response
- 2015
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Ingår i: Journal of intensive care medicine. - : SAGE Publications. - 1525-1489 .- 0885-0666. ; 52:1, s. 493-4
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
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| 53. |
- Fritzell, Peter, et al.
(författare)
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Bacteria : back pain, leg pain and Modic sign—a surgical multicentre comparative study
- 2019
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Ingår i: European spine journal. - : Springer. - 0940-6719 .- 1432-0932. ; 28:12, s. 2981-2989
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To compare bacterial findings in pain-generating degenerated discs in adults operated on for lumbar disc herniation (LDH), and mostly also suffering from low back pain (LBP), with findings in adolescent patients with non-degenerated non-pain-generating discs operated on for scoliosis, and to evaluate associations with Modic signs on magnetic resonance imaging (MRI). Cutibacterium acnes (Propionibacterium acnes) has been found in painful degenerated discs, why it has been suggested treating patients with LDH/LBP with antibiotics. As multidrug-resistant bacteria are a worldwide concern, new indications for using antibiotics should be based on solid scientific evidence.Methods: Between 2015 and 2017, 40 adults with LDH/LBP (median age 43, IQR 33–49) and 20 control patients with scoliosis (median age 17, IQR 15–20) underwent surgery at seven Swedish hospitals. Samples were cultured from skin, surgical wound, discs and vertebrae. Genetic relatedness of C. acnes isolates was investigated using single-nucleotide polymorphism analysis. DNA samples collected from discs/vertebrae were analysed using 16S rRNA-based PCR sequencing. MRI findings were assessed for Modic changes.Results: No bacterial growth was found in 6/40 (15%) LDH patients, compared with 3/20 (15%) scoliosis patients. Most positive samples in both groups were isolated from the skin and then from subcutis or deep within the wound. Of the four disc and vertebral samples from each of the 60 patients, 235/240 (98%) were DNA negative by bacterial PCR. A single species, C. acnes, was found exclusively in the disc/vertebra from one patient in each group. In the LDH group, 29/40 (72%) patients had at least one sample with growth of C. acnes, compared to 14/20 (70%) in the scoliosis group. Bacterial findings and Modic changes were not associated.Conclusions: Cutibacterium acnes found in discs and vertebrae during surgery for disc herniation in adults with degenerated discs may be caused by contamination, as findings in this group were similar to findings in a control group of young patients with scoliosis and non-degenerated discs. Furthermore, such findings were almost always combined with bacterial findings on the skin and/or in the wound. There was no association between preoperative Modic changes and bacterial findings. Antibiotic treatment of lumbar disc herniation with sciatica and/or low back pain, without signs of clinical discitis/spondylitis, should be seriously questioned.
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| 54. |
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| 55. |
- Haapala, Hermanni, et al.
(författare)
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Surgical and Health-related Quality of life Outcomes in Children With Congenital Scoliosis During 5-year Follow-up. Comparison to Age and Sex-matched Healthy Controls
- 2023
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Ingår i: Journal of Pediatric Orthopaedics. - : Ovid Technologies (Wolters Kluwer Health). - 0271-6798 .- 1539-2570. ; 43:6, s. E451-E457
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Tidskriftsartikel (refereegranskat)abstract
- Background:Congenital spinal anomalies represent a heterogeneous group of spinal deformities, of which only progressive or severe curves warrant surgical management. Only a limited number of studies have investigated the impact of surgery on the health-related quality of life and very limited data exists comparing these outcomes to healthy controls.Methods:A single surgeon series of 67 consecutive children with congenital scoliosis (mean age at surgery 8.0 y, range: 1.0 to 18.3 y, 28 girls) undergoing hemivertebrectomy (n = 34), instrumented spinal fusion (n = 20), or vertical expandable prosthetic titanium rib procedure (n = 13) with a mean follow-up of 5.8 years (range: 2 to 13 y). The comparison was made to age and sex-matched healthy controls. Outcome measures included the Scoliosis Research Society questionnaire both pre and postoperatively, radiographic outcomes, and complications.Results:The average major curve correction was significantly better in the hemivertebrectomy (60%) and instrumented spinal fusion (51%) than in the vertical expandable prosthetic titanium rib group (24%), respectively (P < 0.001). Complications were noted in 8 of 67 (12%) children, but all patients recovered fully during follow-up. Pain, self-image, and function domains improved numerically from preoperative to final follow-up, but the pain score was the only one with a statistically significant change (P = 0.033). The Scoliosis Research Society pain, self-image, and function domain scores remained at a significantly lower level at the final follow-up than in the healthy controls (P <= 0.05), while activity scores improved to a similar level.Conclusions:Surgery for congenital scoliosis improved angular spinal deformities with a reasonable risk of complications. Health-related quality of life outcomes improved from preoperative to final follow-up, but especially pain and function domains remained at a significantly lower level than in the age and sex-matched healthy controls.
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| 56. |
- Hedberg, Suzanne, et al.
(författare)
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BEST: Bypass equipoise sleeve trial; rationale and design of a randomized, registry-based, multicenter trial comparing Roux-en-Y gastric bypass with sleeve gastrectomy
- 2019
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Ingår i: Contemporary Clinical Trials. - : Elsevier BV. - 1551-7144 .- 1559-2030. ; 84
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Tidskriftsartikel (refereegranskat)abstract
- Background: Laparoscopic gastric bypass (LGBP) is a well-documented surgical intervention for severe obesity. Recently, laparoscopic sleeve gastrectomy (LSG) has gained increased popularity. Short-term follow-up in limited-sized randomized trials comparing LGBP and LSG show no major differences in weight-loss, adverse events, or effect on comorbidities; however, there is a lack of sufficiently powered, pragmatic, randomized controlled trials comparing the mid- and long-term results of the two methods. Method: BEST is a randomized, registry-based, multicenter trial comparing LGBP and LSG. The trial has two primary outcomes; rates of substantial complications (SC) and total body weight loss. We hypothesize that patients treated with LSG will experience 35% fewer substantial complications during the 5-year follow-up compared to patients treated with LGBP, and that the efficacy of LSG will remain within a non-inferiority margin of 5% in terms of weight loss. Our sample size calculation, using data from the Scandinavian Obesity Surgery Registry (SOReg), shows a power of 80% for SC and > 95% for weight loss at p < .025 with a total of 2100 included patients. The design of the trial will also enable comparisons within several relevant patient subgroups. Conclusions: As a large-sized, pragmatic, randomized trial, BEST will provide robust data comparing LGBP with LSG by generating long-term results on weight loss and SC's, as well as secondary outcomes and comparisons within patient subgroups. The use of a well-established registry for registration of all data facilitates a large multicenter trial, and combines the strengths of registry studies with those of a randomized trial. Clinical Trials registry: NCT 02767505. © 2019 Elsevier Inc.
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| 57. |
- Holy, Marek, 1981-, et al.
(författare)
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A Novel Treatment of Pediatric Atlanto-Occipital Dislocation with Nonfusion Using Muscle-Preserving Temporary Internal Fixation of C0-C2 : Case Series and Technical Note
- 2023
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Ingår i: Journal of Neurological Surgery Reports. - : Georg Thieme Verlag KG. - 2193-6358 .- 2193-6366. ; 84:01, s. E11-E16
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Tidskriftsartikel (refereegranskat)abstract
- Study Design: Case series with surgical technical note.Objectives: This article reports experiences and results of muscle-preserving temporary C0-C2 fixation for the treatment of atlanto-occipital dislocation (AOD).Methods: AOD is a rare injury caused by high-energy trauma, occurring in less than 1% of pediatric trauma patients. Recommended treatment is C0-C2 fusion which, however, will result in significant loss of mobility in the craniocervical junction (CCJ), especially C1-C2 rotation. An alternative approach, with the ability of preserving mobility in the C1-C2 segment, is a temporary fixation that allows the ligaments to heal, after which the implants can be removed to regain function in the CCJ joints. By using a muscle-preserving approach and navigation for the C2 screws, a relatively atraumatic fixation of the CCJ can be achieved with motion recovery after implant removal.Results: We present two cases of AOD treated with temporary fixation. A 12-year-old boy involved in a frontal car collision, as a strapped back seat passenger, was treated with temporary C0-C2 fixation for 10 months. Follow-up at 11 months after implant removal included clinical evaluation, computed tomography, magnetic resonance imaging (MRI), and flexion-extension X-rays. He was free of symptoms at follow-up. The CCJ was radiographically stable and he had 45 degrees of C1-C2 rotation.A 7-year-old girl was hit by a car as she got off a bus. She was treated with temporary fixation for 4 months after which the implant was removed. Follow-up at 8 years included clinical evaluation and MRI in rotation. She was free of symptoms. The ligaments of the CCJ appeared normal and her C1-C2 rotation was 30 degrees.Conclusion: C0-C2 fixation without fusion allows the CCJ ligaments to heal in pediatric AOD. By removing the implants after ligament healing, rotation in the C1-C2 segment can be regained without subsequent instability. Both our patients tolerated the treatment well and were free of symptoms at follow-up.By using minimally invasive muscle-preserving technique and navigation, temporary fixation of the CCJ can be achieved with minimal damage to the soft tissues allowing recovery of almost normal function after implant removal.
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| 58. |
- Hoogervorst, Lotje A., et al.
(författare)
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Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle : A Systematic Review
- 2023
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Ingår i: International Journal of Health Policy and Management. - : Kerman University of Medical Sciences. - 2322-5939. ; 12:1, s. 1-11
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Forskningsöversikt (refereegranskat)abstract
- Background: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformite Europeenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes.Methods: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes.Results: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations.Conclusion: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.
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| 59. |
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| 60. |
- Hägglund, Gunnar, et al.
(författare)
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Prevention of dislocation of the hip in children with cerebral palsy. The first ten years of a population-based prevention programme.
- 2005
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Ingår i: Journal of Bone and Joint Surgery: British Volume. - 2044-5377. ; 87:1, s. 95-101
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Tidskriftsartikel (refereegranskat)abstract
- In 1994, a register for cerebral palsy and a health-care programme were started in southern Sweden with the aim of preventing dislocation of the hip in children with cerebral palsy. It involved all children with cerebral palsy born in 1992 or later. None of the 206 affected children born between 1992 and 1997 has developed a dislocation following the introduction of the prevention programme. Another 48 children moved into the area and none developed any further dislocation. Of the 251 children with cerebral palsy, aged between five and 11 years, living in the area on January 1, 2003, only two had a dislocated hip. One boy had moved into the area at age of nine with a dislocation and a girl whose parents chose not to participate in the programme developed bilateral dislocation. One boy, whose condition was considered to be too poor for preventative surgery, developed a painful dislocation of the hip at the age of five years and died three years later. Eight of 103 children in a control group, consisting of all children with cerebral palsy living in the area between 1994 and 2002, and born between 1990 and 1991, developed a dislocation of the hip before the age of six years. The decreased incidence of dislocation after the introduction of the prevention programme was significant (p < 0.001). Dislocation of the hip in cerebral palsy remains a serious problem, and prevention is important. Our screening programme and early intervention when lateral displacement of the femoral head was detected appear to be successful.
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