Background & purpose. Measurement inconsistency across clinical trials is tackled by the development of a core outcome measurement set. Four core outcome domains were recommended for clinical trials in patients with non-specific LBP (nsLBP): physical functioning, pain intensity, health-related quality of life (HRQoL), and number of deaths. This study aimed to reach consensus on core instruments to measure the first three domains. Methods & Results. The Steering Committee overseeing this project selected 17 potential core instruments for physical functioning, three for pain intensity, and five for HRQoL. Evidence on their measurement properties in nsLBP was synthesized in three systematic reviews using COSMIN methodology. Researchers, clinicians, and patients (n = 208) were invited in a Delphi survey to seek consensus on which instruments to endorse as core. Consensus was a-priori set at 67% of participants agreeing on endorsing an instrument. Two Delphi rounds were run (response rates = 44% and 41%). Agreement was reached on endorsing the Oswestry Disability Index (ODI 2.1a) for physical functioning, the Numeric Rating Scale (NRS) for pain intensity, but not on other instruments. Several participants demanded to have free of charge core instruments. Taking these results into account, the steering committee formulated the following recommendations: ODI 2.1a or 24-item Roland Morris Disability Questionnaire for physical functioning, NRS for pain intensity, Short-Form 12 or 10-item PROMIS Global Health for HRQoL. Conclusion. A core outcome measurement set is available for clinical trials in patients with nsLBP. High quality clinimetric studies directly comparing recommended and not recommended instruments are required. Conflict of interest: None. Source of funding: EUROSPINE, The Spine Society of Europe

Background and Purpose. The STarT Back approach comprises subgrouping of LBP patients according to risk of persistent LBP-related disability, and matches patients to appropriate treatments. In a clinical trial and implementation study, this stratified care approach was clinically and cost-effective compared to usual non-stratified care. However, the long-term cost- effectiveness is unknown, and could be established with decision modelling. A systematic review of model-based economic evaluations in LBP found shortcomings with existing models, including inadequate characterisation of the condition in health states and absence of long-term modelling. This study conceptualises the first decision model of this stratified care approach for LBP management, and assesses long-term cost-effectiveness. Methods. A cost-utility analysis from the NHS perspective compared stratified care with usual care, in patients consulting in primary care with non-specific LBP. A Markov state-transition model was constructed where long-term patient prognosis over ten years was dependent upon physical function achieved at twelve months. Consultation with experts helped define condition health states, inform the long-term modelling, and choice of sensitivity analyses. Results. Preliminary base-case results indicate this model of stratified care is cost-effective over a ten-year time horizon, delivering 0.10 additional quality-adjusted life years (QALYs) at a cost-saving of £100.27 per patient. Sensitivity analyses indicate the approach is likely to be cost-effective in all scenarios, and cost-saving in most, although sensitive to assumptions regarding long-term patient prognosis. Analysis from the societal perspective improved the associated cost-savings. Conclusion. It is likely that implementation of this stratified care model will help reduce unnecessary healthcare usage, whilst improving patient quality of life. No conflicts of interest. Funding: Research stipend for JAH by the Institute for Primary Care & Health Sciences, Keele University

Background and Purpose. Healthcare for sciatica is usually ‘stepped’ with initial advice and analgesia, then physiotherapy, then more invasive interventions if symptoms continue. The SCOPiC trial tested a stratified care algorithm combining prognostic and clinical characteristics to allocate patients into one of three groups, with matched care pathways, and compared the effectiveness of stratified care (SC) with non-stratified, usual care (UC). Methods. Pragmatic two-parallel arm RCT with 476 adults recruited from 42 GP practices and randomised (1:1) to either SC or UC (238 per arm). In SC, participants in group 1 were offered up to 2 advice/treatment sessions with a physiotherapist, group 2 were offered up to 6 physiotherapy sessions, and group 3 was ‘fast-tracked’ to MRI and spinal specialist opinion. Primary outcome was time to first resolution of sciatica symptoms (6-point ordinal scale) collected via text messages. Secondary outcomes (4 and 12 months) included leg and back pain intensity, physical function, psychological status, time-off-work, satisfaction with care. Primary analysis was by intention to treat. Results. Primary outcome data were obtained from 89.3% (88.3% SC, 90.3% UC). Survival analysis showed a small but not statistically significant difference in time to resolution of symptoms (SC reached resolution 2 weeks earlier than UC; HR 1.14 (95% CI 0.89, 1.46)). There were no significant between-arm differences in secondary outcomes. Conclusion. The SC model, tested in this trial was not more effective than UC. On average, patients in both arms made similar good improvements over time, on most outcomes. No conflicts of interest. Funding: This report presents independent research commissioned by the National Institute for Health Research (NIHR) (NIHR HTA project number 12/201/09). NEF is a Senior NIHR Investigator and was supported through an NIHR Research Professorship (NIHR-RP-011-015). KK was supported by a HEFCE Senior Clinical Lectureship award. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, CCF, NETSCC, the Health Technology Assessment programme or the Department of Health

Aims

The aim of this study was to compare outcomes after growth-friendly treatment for early-onset scoliosis (EOS) between patients with skeletal dysplasias versus those with other syndromes.

Aims

Symptomatic spinal stenosis is a very common problem, and decompression surgery has been shown to be superior to nonoperative treatment in selected patient groups. However, performing an instrumented fusion in addition to decompression may avoid revision and improve outcomes. The aim of the SpInOuT feasibility study was to establish whether a definitive randomized controlled trial (RCT) that accounted for the spectrum of pathology contributing to spinal stenosis, including pelvic incidence-lumbar lordosis (PI-LL) mismatch and mobile spondylolisthesis, could be conducted.

Cardiac disease in patients with ankylosing spondylitis (AS) has previously been studied but not in patients with a kyphosis or in those who have undergone an operation to correct it. . The aim of this study was to measure the post-operative changes in cardiac function of patients with an AS kyphosis after pedicle subtraction osteotomy (PSO). The original cohort consisted of 39 patients (33 men, six women). Of these, four patients (two men, two women) were lost to follow-up leaving 35 patients (31 men, four women) to study. The mean age of the remaining patients was 37.4 years (22.3 to 47.8) and their mean duration of AS was 17.0 years (4.6 to 26.4). Echocardiographic measurements, resting heart rate (RHR), physical function score (PFS), and full-length standing spinal radiographs were obtained before surgery and at the two-year follow-up. The mean pre-operative RHR was 80.2 bpm (60.6 to 112.3) which dropped to a mean of 73.7 bpm (60.7 to 90.6) at the two-year follow-up (p = 0.0000). Of 15 patients with normal ventricular function pre-operatively, two developed mild left ventricular diastolic dysfunction (LVDD) at the two-year follow-up. Of 20 patients with mild LVDD pre-operatively only five had this post-operatively. Overall, 15 patients had normal LV diastolic function before their operation and 28 patients had normal LV function at the two-year follow-up. The clinical improvement was 15 out of 20 (75.0%): cardiac function in patients with AS whose kyphosis was treated by PSO was significantly improved. Cite this article: Bone Joint J 2015;97-B:1405–10

Purpose & Background. The STarT Back risk-stratification approach uses the STarT Back Tool to categorise patients with low back pain (LBP) at low, medium or high-risk of persistent disabling pain, in order to match treatments. The MATCH trial (NCT02286141) evaluated the effect of implementing an adaptation of this approach in a United States healthcare setting. Methods. This was a pragmatic cluster randomised trial with a pre-intervention baseline period. Six primary care clinics were pair-randomised, three to an intensive stratified care quality improvement intervention and three as controls. LBP patients were invited to provide outcomes two weeks after their primary care visit, and two and six months later. Primary outcomes were physical function (RMDQ) and pain (0–10 NRS), and secondary outcomes including healthcare use and treatments provided received. Analysis was intention-to-treat. Results. Patient outcomes were obtained from intervention (n=690) and control (n=864) clinics. At six months between-group differences in adjusted mean change scores did not significantly favour stratified care for RMDQ; 0.50 (95%CI −0.55, 1.55) or pain NRS 0.13 (95%CI −0.37, 0.63). There were no significant between group differences in any secondary patient outcome. Process data showed that the STarT Back tool was used with 47% of LBP patients in the intervention clinics but there was no differences in the treatments provided. Conclusions. Implementation of a LBP stratified care approach in this United States healthcare setting showed moderate use of the STarT Back tool, but no change in treatments received by patients, and no benefits on patient outcomes. Conflicts of interest: None. Sources of funding: Funding for this trial was provided by the Patient Centered Care Research Institute (“Evaluation of a Patient-Centered Risk Stratification Method for Improving Primary Care for Back Pain”: Contract #398) and by the National Center for Complementary and Integrative Health/NIH (“Implementing Evidence-Based Treatments for Persistent Back Pain into Primary Care”: Grant #R21AT0007326). Martin Levine, Diane Piekara, and Pam Rock received support to participate in the quality improvement activities from Group Health. Nadine Foster and Jonathan Hill were supported through an NIHR Research Professorship (NIHR-RP-011-015) to Nadine Foster. Nadine Foster is an NIHR Senior Investigator. The views expressed are those of the authors and not necessarily those of the Patient Centered Care Research Institute, NIH, NHS, the NIHR or the Department of Health

We reviewed 15 consecutive patients, 11 women and four men, with a mean age of 48.7 years (37.3 to 62.6), who between July 2004 and August 2007 had undergone percutaneous sacroiliac fusion using hollow modular anchorage screws filled with demineralised bone matrix. Each patient was carefully assessed to exclude other conditions and underwent pre-operative CT and MR scans. The diagnosis of symptomatic sacroiliac disease was confirmed by an injection of local anaesthetic and steroid under image intensifier control. The short form-36 questionnaire and Majeed’s scoring system were used for pre- and post-operative functional evaluation. Post-operative radiological evaluation was performed using plain radiographs. Intra-operative blood loss was minimal and there were no post-operative clinical or radiological complications. The mean follow-up was for 17 months (9 to 39). The mean short form-36 scores improved from 37 (23 to 51) to 80 (67 to 92) for physical function and from 53 (34 to 73) to 86 (70 to 98) for general health (p = 0.037). The mean Majeed’s score improved from 37 (18 to 54) pre-operatively to 79 (63 to 96) post-operatively (p = 0.014). There were 13 good to excellent results. The remaining two patients improved in short form-36 from a mean of 29 (26 to 35) to 48 (44 to 52). Their persistent pain was probably due to concurrent lumbar pathology. We conclude that percutaneous hollow modular anchorage screws are a satisfactory method of achieving sacroiliac fusion

Background. Osteoarthritis (OA) and chronic low back pain (CLBP > 12 weeks duration) are two of the most common and costly chronic musculoskeletal conditions globally. Healthcare service demands mean that group-based multiple condition interventions are of increasing clinical interest and a priority for research, but no reviews have evaluated the effectiveness of group-based physiotherapy-led self-management interventions (GPSMI) for both conditions concurrently. Rapid review methodologies are an increasingly valid means of expediting knowledge dissemination and are particularly useful for addressing focused research questions. Methods. The electronic databases of MEDLINE, EMBASE, CINAHL, Cochrane Database of Systematic Reviews and Cochrane Register of Controlled Trials were searched from the earliest date possible to August 26. th. 2013. Structured group-based interventions that aimed to promote self-management and that were delivered by health-care professionals (including at least one physiotherapist) involving adults with OA and/or CLBP were eligible for inclusion. The screening and selection of studies, data extraction and risk of bias assessment were conducted independently by two reviewers. Results. 22 studies were found (10 OA, 12 CLBP). The most commonly assessed outcomes were pain, disability, quality of life and physical function. No significant difference was found between the effectiveness of GPSMI and individual physiotherapy or usual general practitioner care for any outcome. Conclusion. GPSMI is as clinically effective as individual physiotherapy, but the best methods of measuring clinical effectiveness warrant further investigation. Further research is also needed to determine the cost-effectiveness of GPSMI and its implications. Conflicts of interest: No conflicts of interest. Sources of funding: This review was conducted as part of Health Research Award HRA_HSR/2012/24 from the Health Research Board of Ireland

The “Wallis” implant is indicated to stabilize symptomatic degenerative lumbar spine segments, relieving low back pain related to instability and thus delaying the need for irreversible, more invasive surgical management. The purpose of this study was to provide the first objective clinical evaluation of the “Wallis” lumbar dynamic stabilisation system. An independent prospective observational study was carried out utlising SF-36, Oswestry Disability Index (ODI) and visual analogue pain scores (VAS). Surgical pathologies in which this technique was used, the intra-operative and post-operative complications and length of post-op stay were recorded. 102 patients underwent Wallis insertion between June 2007- May 2009, Median age 51.5 (range 28-108). 94% of patients completed questionnaires and were followed up at 3, 6 and 12 month time points. ODI scores decreased from pre-op 39 to 27 at twelve months (p<.0016). VAS back pain scores decreased 59 to 36 (p<0.0001). Leg scores decreased 50 to 39 (p<0.0002). SF 36 scores improved significantly, physical functioning 46 to 59, physical health 30 to 54 and social functioning 47 to 68. 50% of patients believed their health to be better 12 months post-op. Pre-operatively 28% of patients were employed and working with 26% off work due to back problems. This rate increased steadily with 42% employed at 12 months. Two implants were removed, one due to non-benefit with subsequent arthrodesis and one due to infection. One superficial wound infection occurred. The Wallis dynamic stabilization system provides a superficial and easily reversible surgical procedure with a lower complication rate than conventional athrodesis. Used in patients with painful degenerative lumbar conditions their quality of life objectively approached values of the age- and gender-matched general population

Aims. To report the outcome of spinal deformity correction through anterior spinal fusion in wheelchair-bound patients with myelomeningocele. Methods. We reviewed 12 consecutive patients (7M:5F; mean age 12.4 years (9.2 to 16.8)) including demographic details, spinopelvic parameters, surgical correction, and perioperative data. We assessed the impact of surgery on patient outcomes using the Spina Bifida Spine Questionnaire and a qualitative questionnaire. Results. The mean follow-up was 5.4 years (2 to 14.9). Nine patients had kyphoscoliosis, two lordoscoliosis, and one kyphosis. All patients had a thoracolumbar deformity. Mean scoliosis corrected from 89.6° (47° to 151°) to 46.5° (17° to 85°; p < 0.001). Mean kyphosis corrected from 79.5° (40° to 135°) to 49° (36° to 65°; p < 0.001). Mean pelvic obliquity corrected from 19.5° (8° to 46°) to 9.8° (0° to 20°; p < 0.001). Coronal and sagittal balance restored to normal. Complication rate was 58.3% (seven patients) with no neurological deficits, implant failure, or revision surgery. The degree of preoperative spinal deformity, especially kyphosis and lordosis, correlated with increased blood loss and prolonged hospital/intensive care unit stay. The patients reported improvement in function, physical appearance, and pain after surgery. The parents reported decrease in need for everyday care. Conclusion. Anterior spinal fusion achieved satisfactory deformity correction with high perioperative complication rates, but no long-term sequelae among children with high level myelomeningocele. This resulted in physical and functional improvement and high reported satisfaction. Cite this article: Bone Joint J 2021;103-B(6):1133–1141

Aims

To study the associations of lumbar developmental spinal stenosis (DSS) with low back pain (LBP), radicular leg pain, and disability.

Aims

The aim of this study was to investigate the clinical and radiographic outcomes of microendoscopic laminotomy in patients with lumbar stenosis and concurrent degenerative spondylolisthesis (DS), and to determine the effect of this procedure on spinal stability.

Lumbar disc herniation (LDH) is uncommon in youth and few cases are treated surgically. Very few outcome studies exist for LDH surgery in this age group. Our aim was to explore differences in gender in pre-operative level of disability and outcome of surgery for LDH in patients aged ≤ 20 years using prospectively collected data.

From the national Swedish SweSpine register we identified 180 patients with one-year and 108 with two-year follow-up data ≤ 20 years of age, who between the years 2000 and 2010 had a primary operation for LDH.

Both male and female patients reported pronounced impairment before the operation in all patient reported outcome measures, with female patients experiencing significantly greater back pain, having greater analgesic requirements and reporting significantly inferior scores in EuroQol (EQ-5D-index), EQ-visual analogue scale, most aspects of Short Form-36 and Oswestry Disabilities Index, when compared with male patients. Surgery conferred a statistically significant improvement in all registered parameters, with few gender discrepancies. Quality of life at one year following surgery normalised in both males and females and only eight patients (4.5%) were dissatisfied with the outcome. Virtually all parameters were stable between the one- and two-year follow-up examination.

LDH surgery leads to normal health and a favourable outcome in both male and female patients aged 20 years or younger, who failed to recover after non-operative management.

Cite this article: Bone Joint J 2015;97-B:1675–82.

Aims

The purpose of this prospective study was to evaluate the outcomes of coccygectomy for patients with chronic coccydynia.

The purpose of this study was to evaluate the long-term outcome of adults with spina bifida cystica (SBC) who had been treated either operatively or non-operatively for scoliosis during childhood.

We reviewed 45 patients with a SBC scoliosis (Cobb angle ≥ 50º) who had been treated at one of two children’s hospitals between 1991 and 2007. Of these, 34 (75.6%) had been treated operatively and 11 (24.4%) non-operatively. After a mean follow-up of 14.1 years (standard deviation (sd) 4.3) clinical, radiological and health-related quality of life (HRQOL) outcomes were evaluated using the Spina Bifida Spine Questionnaire (SBSQ) and the 36-Item Short Form Health Survey (SF-36).

Although patients in the two groups were demographically similar, those who had undergone surgery had a larger mean Cobb angle (88.0º (sd 20.5; 50.0 to 122.0); versus 65.7º (sd 22.0; 51.0 to 115.0); p < 0.01) and a larger mean clavicle–rib intersection difference (12.3 mm; (sd 8.5; 1 to 37); versus 4.1 mm, (sd 5.9; 0 to 16); p = 0.01) than those treated non-operatively. Both groups were statistically similar at follow-up with respect to walking capacity, neurological motor level, sitting balance and health-related quality of life (HRQOL) outcomes.

Spinal fusion in SBC scoliosis corrects coronal deformity and stops progression of the curve but has no clear effect on HRQOL.

Cite this article: Bone Joint J 2014; 96-B:1244–51

Total en bloc spondylectomy (TES) is the total resection of a vertebra containing a tumour. Many authors have investigated patient-reported outcomes after routine spinal surgery and surgery for tumours in general. However, this is the first report of patient-reported outcomes, including health-related quality of life (HRQoL) and satisfaction, after en bloc vertebral resection for a spinal tumour.

Of the 54 patients who underwent TES for a primary tumour between 1993 and 2010, 19 died and four were lost to follow-up. In January 2012, a questionnaire was sent to the 31 surviving patients. This included the short form-36 to assess HRQoL and questions about the current condition of their disease, activities of daily living (ADL) and surgery. The response rate was high at 83.9% (26/31 patients). We found that most patients were satisfied and maintained good performance of their ADLs.

The mental health status and social roles of the HRQoL scores were nearly equivalent to those of healthy individuals, regardless of the time since surgery. There was significant impairment of physical health in the early post-operative years, but this usually returned to normal approximately three years after surgery.

Cite this article: Bone Joint J 2014;96-B:1693–8.

This article reviews the current knowledge of the intervertebral disc (IVD) and its association with low back pain (LBP). The normal IVD is a largely avascular and aneural structure with a high water content, its nutrients mainly diffusing through the end plates. IVD degeneration occurs when its cells die or become dysfunctional, notably in an acidic environment. In the process of degeneration, the IVD becomes dehydrated and vascularised, and there is an ingrowth of nerves. Although not universally the case, the altered physiology of the IVD is believed to precede or be associated with many clinical symptoms or conditions including low back and/or lower limb pain, paraesthesia, spinal stenosis and disc herniation.

New treatment options have been developed in recent years. These include biological therapies and novel surgical techniques (such as total disc replacement), although many of these are still in their experimental phase. Central to developing further methods of treatment is the need for effective ways in which to assess patients and measure their outcomes. However, significant difficulties remain and it is therefore an appropriate time to be further investigating the scientific basis of and treatment of LBP.

Few studies have examined the order in which a spinal osteotomy and total hip replacement (THR) are to be performed for patients with ankylosing spondylitis. We have retrospectively reviewed 28 consecutive patients with ankylosing spondylitis who underwent both a spinal osteotomy and a THR from September 2004 to November 2012. In the cohort 22 patients had a spinal osteotomy before a THR (group 1), and six patients had a THR before a spinal osteotomy (group 2). The mean duration of follow-up was 3.5 years (2 to 9). The spinal sagittal Cobb angle of the vertebral osteotomy segment was corrected from a pre-operative kyphosis angle of 32.4 (SD 15.5°) to a post-operative lordosis 29.6 (SD 11.2°) (p < 0.001). Significant improvements in pain, function and range of movement were observed following THR. In group 2, two of six patients had an early anterior dislocation. The spinal osteotomy was performed two weeks after the THR. At follow-up, no hip has required revision in either group. Although this non-comparative study only involved a small number of patients, given our experience, we believe a spinal osteotomy should be performed prior to a THR, unless the deformity is so severe that the procedure cannot be performed.

Cite this article: Bone Joint J 2014;96-B:360–5.

Osteoporotic vertebral compression fractures (VCFs) are an increasing public health problem. Recently, randomised controlled trials on the use of kyphoplasty and vertebroplasty in the treatment of these fractures have been published, but no definitive conclusions have been reached on the role of these interventions. The major problem encountered when trying to perform a meta-analysis of the available studies for the use of cementoplasty in patients with a VCF is that conservative management has not been standardised. Forms of conservative treatment commonly used in these patients include bed rest, analgesic medication, physiotherapy and bracing.

In this review, we report the best evidence available on the conservative care of patients with osteoporotic VCFs and associated back pain, focusing on the role of the most commonly used spinal orthoses. Although orthoses are used for the management of these patients, to date, there has been only one randomised controlled trial published evaluating their value. Until the best conservative management for patients with VCFs is defined and standardised, no conclusions can be drawn on the superiority or otherwise of cementoplasty techniques over conservative management.