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The Bone & Joint Journal
Vol. 104-B, Issue 12 | Pages 1343 - 1351
1 Dec 2022
Karlsson T Försth P Skorpil M Pazarlis K Öhagen P Michaëlsson K Sandén B

Aims

The aims of this study were first, to determine if adding fusion to a decompression of the lumbar spine for spinal stenosis decreases the rate of radiological restenosis and/or proximal adjacent level stenosis two years after surgery, and second, to evaluate the change in vertebral slip two years after surgery with and without fusion.

Methods

The Swedish Spinal Stenosis Study (SSSS) was conducted between 2006 and 2012 at five public and two private hospitals. Six centres participated in this two-year MRI follow-up. We randomized 222 patients with central lumbar spinal stenosis at one or two adjacent levels into two groups, decompression alone and decompression with fusion. The presence or absence of a preoperative spondylolisthesis was noted. A new stenosis on two-year MRI was used as the primary outcome, defined as a dural sac cross-sectional area ≤ 75 mm2 at the operated level (restenosis) and/or at the level above (proximal adjacent level stenosis).


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 705 - 712
1 Jul 2024
Karlsson T Försth P Öhagen P Michaëlsson K Sandén B

Aims

We compared decompression alone to decompression with fusion surgery for lumbar spinal stenosis, with or without degenerative spondylolisthesis (DS). The aim was to evaluate if five-year outcomes differed between the groups. The two-year results from the same trial revealed no differences.

Methods

The Swedish Spinal Stenosis Study was a multicentre randomized controlled trial with recruitment from September 2006 to February 2012. A total of 247 patients with one- or two-level central lumbar spinal stenosis, stratified by the presence of DS, were randomized to decompression alone or decompression with fusion. The five-year Oswestry Disability Index (ODI) was the primary outcome. Secondary outcomes were the EuroQol five-dimension questionnaire (EQ-5D), visual analogue scales for back and leg pain, and patient-reported satisfaction, decreased pain, and increased walking distance. The reoperation rate was recorded.


Bone & Joint Open
Vol. 5, Issue 7 | Pages 612 - 620
19 Jul 2024
Bada ES Gardner AC Ahuja S Beard DJ Window P Foster NE

Aims. People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians’ views about the suitability of patients for such a future trial, along with their views regarding equipoise for randomizing patients in a future clinical trial comparing lumbar spine fusion surgery to best conservative care (BCC; the FORENSIC-UK trial). Methods. An online cross-sectional survey was piloted by the multidisciplinary research team, then shared with clinical professional groups in the UK who are involved in the management of adults with severe, persistent LBP. The survey had seven sections that covered the demographic details of the clinician, five hypothetical case vignettes of patients with varying presentations, a series of questions regarding the preferred management, and whether or not each clinician would be willing to recruit the example patients into future clinical trials. Results. There were 72 respondents, with a response rate of 9.0%. They comprised 39 orthopaedic spine surgeons, 17 neurosurgeons, one pain specialist, and 15 allied health professionals. Most respondents (n = 61,84.7%) chose conservative care as their first-choice management option for all five case vignettes. Over 50% of respondents reported willingness to randomize three of the five cases to either surgery or BCC, indicating a willingness to participate in the future randomized trial. From the respondents, transforaminal interbody fusion was the preferred approach for spinal fusion (n = 19, 36.4%), and the preferred method of BCC was a combined programme of physical and psychological therapy (n = 35, 48.5%). Conclusion. This survey demonstrates that there is uncertainty about the role of lumbar spine fusion surgery and BCC for a range of example patients with severe, persistent LBP in the UK. Cite this article: Bone Jt Open 2024;5(7):612–620


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_I | Pages 34 - 34
1 Jan 2012
Bronfort G Maiers M Schulz C Evans R Bracha Y Svendsen K Grimm R Owens E Garvey T Transfeldt E
Full Access

Purpose. The importance of interpreting clinical trial results in terms of the benefits a treatment may offer to individuals with chronic pain is becoming more widely recognized. The clinical meaningfulness of group differences can better be described by looking at the percentages of responders in each treatment group, rather than between group mean differences. We have reassessed the outcomes of a clinical trial for chronic low back pain (LBP) from this new perspective. Methods. The randomized clinical trial examined short- (12 weeks) and long-term (52 weeks) efficacy of high-dose, supervised trunk exercise (SET), spinal manipulative therapy (SMT), and a course of home exercise and self-care advice (HEA) for the treatment of LBP ≥ 6 weeks duration. We calculated response to care at 2 levels for 2 variables: numeric back pain scores (NRS) and Roland-Morris Disability (RMD), and at 3 timepoints (Weeks 12, 26 and 52). The 2 levels were calculated as percent improvement from baseline ≥ 30% and ≥75%. Finally, we calculated the relative proportion (± 95% confidence intervals) of the sample (∼100 per treatment group) that achieved each level of improvement. Conclusion. In general, 60%-80% of patients had ≥ 30% improvements in pain @ week 12, while 20%-30% showed ≥75% improvement. At week 52, the percentage of patients with ≥ 30% improvement dropped slightly, while ≥75% improvement increased slightly. For RMD scores, 30%-50% of patients showed ≥75% improvement at week 52. We will present these results and compare them to the previous analysis of between group mean differences


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_I | Pages 54 - 54
1 Jan 2012
Mieritz RM
Full Access

Advisors. PhD J Hartvigsen, PhD P Aagaard, University of Southern Denmark. PhD G Br⊘nfort, Northwestern Health Sciences University, Minneapolis, MN, USA and NIKKB. PhD G Kawchuk, Canada Research Chair in Spinal Function, University of Edmonton, Alberta, Canada. PhD A Breen, Institute for muscoloskeletal research & clinical implementation, Bournemouth, England. PhD J Rasmussen, Institut for Maskinteknik og Anybody Group, Aalborg Universitet. Introduction. The overall issue of this project is to investigate the relationship between the lumbar spinal biomechanics, patient's pain and physiological effects of traditional conservative treatments. Background. Biomechanical factors such as ranges, patterns and quality of motion in the lumbar spine are thought to be important contributors to many varieties of LBP. Furthermore, commonly used treatments for spine pain such as exercises, training, and various manual treatments such as manipulation are thought to alter biomechanical factors and thereby facilitating return to “normal” function and thus a pain free state. Method. A systematic critical literature review in order to determine the current reproducibility level for measuring 3D regional lumbar spinal motion with various methods and based on the review propose an agenda for future research. Develop of a model to analyze the dynamic non-invasive computerized regional motion data. In this model the complex motion data will be reduced to a manageable size with each movement parameter consisting of individual figures. The data reduction will be done in a developed MATLAB program and the analysis of the reduced data will be handled in STATA. Use collected data from randomized clinical trials (research center at Northwestern Health Sciences University in Minnesota, USA) on the developed model in a reproducibility study and an intervention study


Aims

The optimal procedure for the treatment of ossification of the posterior longitudinal ligament (OPLL) remains controversial. The aim of this study was to compare the outcome of anterior cervical ossified posterior longitudinal ligament en bloc resection (ACOE) with posterior laminectomy and fusion with bone graft and internal fixation (PTLF) for the surgical management of patients with this condition.

Methods

Between July 2017 and July 2019, 40 patients with cervical OPLL were equally randomized to undergo surgery with an ACOE or a PTLF. The clinical and radiological results were compared between the two groups.


Bone & Joint Research
Vol. 7, Issue 2 | Pages 124 - 130
1 Feb 2018
Coric D Bullard DE Patel VV Ryaby JT Atkinson BL He D Guyer RD

Objectives. Pulsed electromagnetic field (PEMF) stimulation was evaluated after anterior cervical discectomy and fusion (ACDF) procedures in a randomized, controlled clinical study performed for United States Food and Drug Administration (FDA) approval. PEMF significantly increased fusion rates at six months, but 12-month fusion outcomes for subjects at elevated risk for pseudoarthrosis were not thoroughly reported. The objective of the current study was to evaluate the effect of PEMF treatment on subjects at increased risk for pseudoarthrosis after ACDF procedures. Methods. Two evaluations were performed that compared fusion rates between PEMF stimulation and a historical control (160 subjects) from the FDA investigational device exemption (IDE) study: a post hoc (PH) analysis of high-risk subjects from the FDA study (PH PEMF); and a multicentre, open-label (OL) study consisting of 274 subjects treated with PEMF (OL PEMF). Fisher’s exact test and multivariate logistic regression was used to compare fusion rates between PEMF-treated subjects and historical controls. Results. In separate comparisons of PH PEMF and OL PEMF groups to the historical control group, PEMF treatment significantly (p < 0.05, Fisher’s exact test) increased the fusion rate at six and 12 months for certain high-risk subjects who had at least one clinical risk factor of being elderly, a nicotine user, osteoporotic, or diabetic; and for those with at least one clinical risk factor and who received at least a two- or three-level arthrodesis. Conclusion. Adjunctive PEMF treatment can be recommended for patients who are at high risk for pseudoarthrosis. Cite this article: D. Coric, D. E. Bullard, V. V. Patel, J. T. Ryaby, B. L. Atkinson, D. He, R. D. Guyer. Pulsed electromagnetic field stimulation may improve fusion rates in cervical arthrodesis in high-risk populations. Bone Joint Res 2018;7:124–130. DOI: 10.1302/2046-3758.72.BJR-2017-0221.R1