Background. Specifically designed control interventions can account for expectation effects in clinical trials. For the interpretation of efficacy trials of physical, psychological, and self-management interventions for people living with pain, the design, conduct, and reporting of control interventions is crucial. Objectives. To establish a quality standard in the field, core recommendations are presented alongside additional considerations and a reporting checklist for control interventions. Methods. Three Delphi rounds with 64 experts in placebo research and/or non-pharmacological clinical trials were conducted. The panel was presented with a systematic review and meta-analysis of control and blinding methods. A draft guidance document included 63 consensus items (≥80% agreement) and was discussed with patient partners. Finally, the draft guidance and results from stakeholder interviews were discussed at consensus meetings with Delphi participants and patient representatives. Results. Forty-four experts completed the process. When treatment efficacy or mechanisms are to be studied, the advocated principle is to design control interventions as similar as possible to the tested intervention, apart from the components that the study examines. Structured reasoning in the planning phase, early engagement with stakeholders, feasibility work, and piloting will enhance the quality and acceptability of control interventions. With participant blinding being a primary objective, blinding effectiveness should be routinely assessed and reported. Transparent and detailed reporting will improve interpretability and repeatability of clinical trials. Conclusion. This guideline provides the much-needed standards to enhance the quality of efficacy clinical trials in physical, psychological, and self-management intervention research, ultimately improving patient care. Study registration: . https://osf.io/jmyhq/. Conflict of interest: The authors declare no competing interests. Sources of Funding: Alain and Sheila Diamond Charitable Trust PhD Studentship

Aims. The aim of this study was to investigate the efficacy of coccygectomy in patients with persistent coccydynia and coccygeal instability. Methods. The Danish National Spine Registry, DaneSpine, was used to identify 134 consecutive patients who underwent surgery, performed by a single surgeon between 2011 and 2019. Routine demographic data, surgical variables, and patient-reported outcomes, including a visual analogue scale (VAS) (0 to 100) for pain, Oswestry Disability Index (ODI), EuroQol five-dimension questionnaire (EQ-5D), and the Physical Component Score (PCS) and Mental Component Score (MCS) of the 36-Item Short-Form Health Survey questionnaire (SF-36) were collected at baseline and one-year postoperatively. Results. A total of 112 (84%) patients with a minimum follow-up of one year had data available for analysis. Their mean age was 41.9 years, and 15 (13%) were males. At 12 months postoperatively, there were statistically significant improvements (p < 0.001) from baseline for the mean VAS for pain (70.99 to 35.34), EQ-5D (0.52 to 0.75), ODI (31.84 to 18.00), and SF-36 PCS (38.17 to 44.74). A total of 78 patients (70%) were satisfied with the outcome of treatment. Conclusion. Patients with persistent coccydynia and coccygeal instability resistant to nonoperative treatment may benefit from coccygectomy. Cite this article: Bone Joint J 2021;103-B(3):542–546

Aims. Spinal fusion remains the gold standard in the treatment of idiopathic scoliosis. However, anterior vertebral body tethering (AVBT) is gaining widespread interest, despite the limited data on its efficacy. The aim of our study was to determine the clinical efficacy of AVBT in skeletally immature patients with idiopathic scoliosis. Methods. All consecutive skeletally immature patients with idiopathic scoliosis treated with AVBT enrolled in a longitudinal, multicentre, prospective database between 2013 and 2016 were analyzed. All patients were treated by one of two surgeons working at two independent centres. Data were collected prospectively in a multicentre database and supplemented retrospectively where necessary. Patients with a minimum follow-up of two years were included in the analysis. Clinical success was set a priori as a major coronal Cobb angle of < 35° at the most recent follow-up. Results. A total of 57 patients were included in the study. Their mean age was 12.7 years (SD 1.5; 8.2 to 16.7), with 95% being female. The mean preoperative Sanders score and Risser grade was 3.3 (SD 1.2), and 0.05 (0 to 3), respectively. The majority were thoracic tethers (96.5%) and the mean follow-up was 40.4 months (SD 9.3). The mean preoperative major curve of 51° (SD 10.9°; 31° to 81°) was significantly improved to a mean of 24.6° (SD 11.8°; 0° to 57°) at the first postoperative visit (45.6% (SD 17.6%; 7% to 107%); p < 0.001)) with further significant correction to a mean of 16.3° (SD 12.8°; -12 to 55; p < 0.001) at one year and a significant correction to a mean of 23° (SD 15.4°; -18° to 57°) at the final follow-up (42.9% (-16% to 147%); p < 0.001). Clinical success was achieved in 44 patients (77%). Most patients reached skeletal maturity, with a mean Risser score of 4.3 (SD 1.02), at final follow-up. The complication rate was 28.1% with a 15.8% rate of unplanned revision procedures. Conclusion. AVBT is associated with satisfactory correction of deformity and an acceptable complication rate when used in skeletally immature patients with idiopathic scoliosis. Improved patient selection and better implant technology may improve the 15.8% rate of revision surgery in these patients. Further scrutiny of the true effectiveness and long-term risks of this technique remains critical. Cite this article: Bone Joint J 2020;102-B(12):1703–1708

Randomised controlled trials (RCTs) that assessed the efficacy of bracing for adolescent idiopathic scoliosis have suffered from small sample sizes, low compliance and lack of willingness to participate. The aim of this study was to assess the feasibility of a comprehensive cohort study for evaluating both the efficacy and the effectiveness of bracing in patients with adolescent idiopathic scoliosis. Patients with curves at greater risk of progression were invited to join a randomised controlled trial. Those who declined were given the option to remain in the study and to choose whether they wished to be braced or observed. Of 87 eligible patients (5 boys and 63 girls) identified over one year, 68 (78%) with mean age of 12.5 years (10 to 15) consented to participate, with a mean follow-up of 168 weeks (0 to 290). Of these, 19 (28%) accepted randomisation. Of those who declined randomisation, 18 (37%) chose a brace. Patients who were more satisfied with their image were more likely to choose bracing (Odds Ratio 4.1; 95% confidence interval 1.1 to 15.0; p = 0.035). This comprehensive cohort study design facilitates the assessment of both efficacy and effectiveness of bracing in patients with adolescent idiopathic scoliosis, which is not feasible in a conventional randomised controlled trial. Cite this article: Bone Joint J 2015; 97-B:973–81

Background. We have reported an injectable L-pNIPAM-co-DMAc hydrogel with hydroxyaptite nanoparticles (HAPna) which promotes mesenchymal stem cell (MSC) differentiation to bone cells without the need for growth factors. This hydrogel could potentially be used as an osteogenic and osteoconductive bone filler of spinal cages to improve vertebral body fusion. Here we investigated the biocompatibility and efficacy of the hydrogel in vivo using a proof of concept femur defect model. Methods. Rat sub-cut analysis was performed to investigate safety in vivo. A rat femur defect model was performed to evaluate efficacy. Four groups were investigated: sham operated controls; acellular L-pNIPAM-co-DMAc hydrogel; acellular L-pNIPAM-co-DMAc hydrogel with HAPna; L-pNIPAM-co-DMAc hydrogel with rat MSCs and HAPna. Following 4 weeks, defect site and organs were histologically examined to determine integration, repair and inflammatory response, as well as Micro-CT to assess mineralisation. Results. No inflammatory reactions or toxicity were seen in any animal. Enhanced bone healing was observed in aged exbreeder female rats where hydrogel was injected with increased deposition of collagen type I. Integration of the hydrogel with surrounding bone was observed without the need for delivered MSCs; native cell infiltration was also seen and bone formation was observed within all hydrogel systems investigated. Conclusion. This novel hydrogel is biocompatible, facilitates migration of cells, promotes increased bone formation and integrates with surrounding bone. This system could be injected to fill spaces within and surrounding spinal cages to aid in cage fixation and spinal fusion without the need for harvesting of bone autografts, thus reducing operative risk and surgical cost. Conflicts of Interest: None. Source of Funding: BMRC, MERI Sheffield Hallam University

Purposes of study and background. The study aim is to evaluate the efficacy of dynamic MRI scanning in identifying radiological causes of positional sciatica over a 5-year period. Summary of methods used and the results. We describe the results of a prospective series of patients who completed open MRI scanning, indicated for lower back pain and positional sciatica. 40 open MRI scans were requested between March 2012 and March 2017. 31 patients were intolerant to conventional MRI Scanning due to either claustrophobia or the inability to lie flat. 9 patients were identified as having positional sciatica. All patients completed the Oswestry Disability Index as part of their clinical assessment. The MRI images and radiology report were reviewed to identify surgically relevant causes. Dynamic foraminal narrowing and a progressive disc protrusion were identified in 2 patients who presented with positional sciatica. 23% of patients who were scanned had positional sciatica. 5% of patients indicated for open MRI scanning demonstrated surgically relevant changes on dynamic MRI scanning. 22% of those with positional sciatica demonstrated surgically relevant pathology on dynamic scanning. Conclusion. The total number of patients having indications for open MRI scans over a 5- year period is low. Dynamic MRI scanning is effective in identifying surgically relevant causes in those patients presenting with positional sciatica. Conflicts of Interest: None. Sources of funding: None

Comparison of efficacy of multi-modality spinal cord monitoring [SCM] (SSEP & MEP) in surgery of paediatric deformity using two classification systems I (traditional) vs. II (modified). SSEP SCM has low sensitivity in a normal spinal cord; this is only marginally improved with additional MEP monitoring. Traditional definitions of a ‘false’ positive' test ignores anaesthetic & surgical interventions following notification of altered SCM signals. Retrospective, paediatric cohort. 232 patients; mean age 14 years (26% males). 68% idiopathic scoliosis; 62% posterior surgery. Primary: Post-operative neurologic deficit. Secondary: significant (>50%↓ amplitude) SSEP or any MEP loss. PPV- Positive predictive value, NPV- Negative predictive value; LR+ve- Positive likelihood ratio, LR-ve Negative likelihood ratio; N/C – Not calculable. Efficacy of SCM is determined by definitions of ‘false positive’. System II classification was more efficacious and reflects current surgical practice

Purpose. To elucidate the efficacy of carrying out additional vertebral biopsy procedure during percutaneous balloon kyphoplasty as a tool in determining malignant etiology. Methods and Results. We performed 138 percutaneous balloon kyphoplasty procedures in 85 patients during august 2007 to march 2010. Gender distribution was 25 males and 60 females. Age distribution was 33 to 85 years, with an average age of 67.4 years. The senior surgeon attempted vertebral biopsy during percutaneous balloon kyphoplasty procedure only when there was a clinical/operative suspicion of malignancy. We did not routinely biopsy all vertebrae, as this would mean additional procedure adding to the cost and operating time. In 42 procedures vertebral biopsy was attempted, of which 5 samples were reported as insufficient specimen. 37 biopsies (88%) were successfully analyzed. 3 biopsies (8.1%) were positive for malignancy. There were no complications encountered in the cases where additional biopsy procedure was carried out. Conclusion. There is not much literature supporting routine use and efficacy of biopsies during percutaneous balloon kyphoplasty procedures. Although the quality of bone could make vertebral biopsy challenging in all cases, we feel that improved technique of taking biopsies and maybe increasingly performing the additional biopsy procedure could detect more positive malignancies. Routine biopsies during percutaneous balloon kyphoplasty may be invaluable in diagnosing malignancies

Aims

The aim of the present study was to answer the question whether curve morphology and location have an influence on rigid conservative treatment in patients with adolescent idiopathic scoliosis (AIS).

To evaluate the efficacy of Vacuum Assisted Closure (VAC) in the management of post surgical spinal sepsis. A retrospective analysis was performed of patients with severe post operative spinal wound infections treated using a combination surgical debridement, antibiotics and VAC therapy. Full records were available for a total of twenty adult all of whom had had prior thoracic or lumbar instrumentation. Comorbidities included disseminated carcinomatosis (25 % of patients), Ankylosing spondylitis (5 %), rheumatoid arthritis (5%) and Polio (5%). In one patient there had been a prior history of irradiation of the surgical field. Most infections treated by this regime were identified within two weeks following surgery. At surgery infection deep to the dorso-lumbar fascia was found in 87 % of cases. It was possible to retain instrumentation in 60 % of cases. An average of three trips to theatre were required prior to wound closure, which was possible in 95 % of cases. The VAC device was left in situ for an average of 11 days. Complications included recurrence of infection necessitating further treatment in 20 % of cases, wound dehiscence necessitating healing by secondary intention in 5%, the need for free flap wound cover in 5 % and death from unrelated causes in 5%. VAC therapy may facilitate the management of wound sepsis following spinal surgery in susceptible patients allowing the maintenance of instrumentation and surgical correction

We evaluated the efficacy of Escherichia coli-derived recombinant human bone morphogenetic protein-2 (E-BMP-2) in a mini-pig model of spinal anterior interbody fusion. A total of 14 male mini-pigs underwent three-level anterior lumbar interbody fusion using polyether etherketone (PEEK) cages containing porous hydroxyapatite (HA). Four groups of cages were prepared: 1) control (n = 10 segments); 2) 50 μg E-BMP-2 (n = 9); 3) 200 μg E-BMP-2 (n = 10); and 4) 800 μg E-BMP-2 (n = 9). At eight weeks after surgery the mini-pigs were killed and the specimens were evaluated by gross inspection and manual palpation, radiological evaluation including plain radiographs and micro-CT scans, and histological analysis. Rates of fusion within PEEK cages and overall union rates were calculated, and bone formation outside vertebrae was evaluated. One animal died post-operatively and was excluded, and one section was lost and also excluded, leaving 38 sites for assessment. This rate of fusion within cages was 30.0% (three of ten) in the control group, 44.4% (four of nine) in the 50 μg E-BMP-2 group, 60.0% (six of ten) in the 200 μg E-BMP-2 group, and 77.8% (seven of nine) in the 800 μg E-BMP-2 group. Fusion rate was significantly increased by the addition of E-BMP-2 and with increasing E-BMP-2 dose (p = 0.046). In a mini-pig spinal anterior interbody fusion model using porous HA as a carrier, the implantation of E-BMP-2-loaded PEEK cages improved the fusion rate compared with PEEK cages alone, an effect that was significantly increased with increasing E-BMP-2 dosage. Cite this article: Bone Joint J 2013;95-B:217–23

Introduction

Current strategies to treat back pain address the symptoms but not the underlying cause. Here we are investigating a novel hydrogel material (NPgel) which can promote MSC differentiation to Nucleus pulposus cells. Current in vitro studies have only explored conditions that mimic the native disc microenvironment. Here, we aim to determine the stem cells regenerative capacity under conditions that mimic the degenerate environment seen during disc degeneration.

Much debate exists over the value of exercise therapy for treating adolescent idiopathic scoliosis (AIS). This study aims to address the current evidence. An extensive search was carried out using the common medical databases, limiting results to clinical trials in English involving humans with defined outcome measures. 155 papers were identified and after applying strict inclusion criteria 12 papers remained for further analysis. These included 9 prospective cohort trials, 2 retrospective cohort trials and one case series. No randomised controlled trials were identified. Although all of the papers concluded an improvement in scoliotic curve after exercise therapy, not one of the papers had reliable methods or results to validate their conclusions. Identified shortcomings included, poor compliance with outpatient exercise regimes with no clear indication of who assessed for curve improvement, how it was assessed or what experience they had, nor was observer error for Cobb angle measurement taken into account. Additionally only a few of the studies had sound statistical analysis and no study could comment on whether the improvements seen were maintained after the exercise regime. Four previous systematic reviews have been performed finding favourable results for exercise therapy, but these were written by authors involved in the original research, adding significant reviewer bias. This systematic review has revealed only poor and low level evidence supporting the use of exercise therapy for treating AIS. Well designed controlled trials with randomisation are required to validate exercise therapy as an effective treatment option and as an appropriate use of NHS funds.

Background

Degenerative spondylolisthesis (DS) with stenosis is now typically treated by decompression and instrumented fusion. This treatment method does produce predictable results at the spondylolisthetic level, but later stenosis will occur commonly at the adjacent level due to the rigidity of the construct. Pedicle screw fusion may also be a significantly invasive procedure for an elderly patient.

To assess radiological fusion rates in posterolateral fusions using SiS-CaP.

Retrospective, radiological follow-up study.

Single surgeon series of 76 consecutive patients were evaluated, in a regional spinal unit. All patients had clinical and radiological (MRI) spinal canal stenosis secondary to degenerative spondylosis or spondylolisthesis. Surgery consisted of instrumentation, decompression and meticulous preparation of the posterolateral graft bed by removal of all soft tissues posterior to the inter-transverse membrane and decortication of transverse processes (TPs). SiS-CaP putty was injected into this gutter and moulded around the instrumentation. Good quality, well prepared bone chips from the posterior decompression were seeded into the putty. Patient radiographs were reviewed at 3-6 months, 1 year and 2 years.

Radiographs were assessed using a protocol to examine granularity, bone formation and evidence of pseudarthrosis, based upon previously reported literature ¹ and our personal experience.

Of the 76 patients, 26 were excluded. M:F was 21:29. Mean age was 58yrs. Average number of motion segments fused per case was 2.2. There was one pseudarthrosis with metalwork fracture, and thus a total fusion rate of 98%. In addition, one patient had scanty bridging of TPs, and one patient had lucency around the S1 screws.

SiS-CaP, as a bone graft substitute in posterolateral instrumented fusions, gives comparable results to published fusion rates using autologous iliac crest grafting and/or Bone Morphogenic Protein ². Moreover, it avoids the associated morbidity of iliac bone harvest.

Aim:

To present the results of multi-modal IOM in 298 patients who underwent spinal deformity correction.

Aims. Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS). Methods. UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination. Discussion. The primary outcome is ‘treatment failure’ (Cobb angle progression to 50° or more before skeletal maturity); skeletal maturity is at Risser stage 4 in females and 5 in males, or ‘treatment success’ (Cobb angle less than 50° at skeletal maturity). The comparison is on a non-inferiority basis (non-inferiority margin 11%). Participants are followed up every six months while in brace, and at one and two years after skeletal maturity. Secondary outcomes include the Scoliosis Research Society 22 questionnaire and measures of quality of life, psychological effects of bracing, adherence, anxiety and depression, sleep, satisfaction, and educational attainment. All data will be collected through the British Spine Registry. Cite this article: Bone Jt Open 2023;4(11):873–880

Background. It has become increasingly important to conduct studies assessing clinical outcomes, reoperation rates, and revision rates to better define the indications and efficacy of lumbar spinal procedures and its association with symptomatic adjacent segment degeneration (sASD). Adjacent segment degeneration (ASD) is defined as the radiographic change in the intervertebral discs adjacent to the surgically treated spinal level. SASD represents adjacent segment degeneration which causes pain or numbness due to post-operative spinal instability or nerve compression at the same level. The most common reason for early reoperation and late operation is sASD, therefore is in our best interest to understand the causes of ASD and make steps to limit the occurrence. Method. A comprehensive literature search was performed selecting Randomized controlled trials (RCTs) and retrospective or prospective studies published up to December 2023. Meta-analysis was performed on 38 studies that met the inclusion criteria and included data of clinical outcomes of patients who had degenerative disc disease, disc herniation, radiculopathy, and spondylolisthesis and underwent lumbar fusion or motion-preservation device surgery; and reported on the prevalence of ASD, sASD, reoperation rate, visual analogue score (VAS), and Oswestry disability index (ODI) improvement. Results. When compared to fusion surgery, a significant reduction of ASD, sASD and reoperation was observed in the cohort of patients that underwent motion-preserving surgery. Conclusion. Dynamic fusion constructs are treatment options that may help to prevent sASD. Conflicts of interest. This research was funded by Paradigm Spine. Sources of funding. Paradigm Spine

Background. Chronic low back pain is strongly linked to degeneration of the intervertebral disc (IVD), which currently lacks any targeted treatments. This study explores NPgel, a biomaterial combined with notochordal cells (NC), developmental precursor cells, as a potential solution. NCs, known for anti-catabolic effects on IVD cells, present a promising avenue for regenerating damaged IVD tissue. Methods. Bovine IVDs underwent enzymatic degeneration before NPgel (+/- NC) injection. Degenerated bovine IVDs were cultured under biomechanical loading for 21 days. Histology and immunohistochemistry assessed NC survival, phenotype, and matrix production. Within an in vivo sheep pilot study, NPgel (+/- NC) was injected into degenerated IVDs, blood was taken, and immune cell activation was monitored via flow cytometry over three months post-injection. Results. Within the ex vivo model, IVDs injected with NPgel (+/- NC) exhibited increased matrix expression and deposition. Viable NCs were detected post-culture, indicating survival and matrix production. In the in vivo model, NPgel injection into sheep IVDs did not significantly increase activation of immune cells compared to controls, suggesting no systemic inflammatory effects. Conclusion. NPgel, combined with NCs, shows promise for IVD regeneration. Ex vivo findings indicate NPgel supports NC survival and matrix production. Moreover, in vivo results demonstrate the absence of systemic immunogenic responses post-NPgel injection. This suggests NPgel's potential as a carrier for NCs in IVD regeneration therapy. These findings underscore NPgel's candidacy for further investigation in addressing chronic low back pain associated with IVD degeneration. Subsequent research, including long-term efficacy and safety evaluations, is imperative for clinical translation. Conflicts of interest. There are no conflicts of interest. Sources of funding. iPSpine, grant # 825925, Horizon 2020

Background. Embodiment- and distraction-based approaches to immersive virtual reality (IVR) show promise in treating persistent low back pain (PLBP). However, which approach is more effective is unclear. This study aims to evaluate the impact of distraction- and embodiment-based IVR on pain processing and patient-reported outcome measures in PLBP. Method. Individuals with PLBP were randomised to receive eight sessions of either distraction- or embodiment-based IVR over two weeks. Outcome measures were evaluated at baseline and after the eighth session. Pain processing was evaluated using conditioned pain modulation (CPM) and temporal summation (TS). Results. Three participants (n=2 embodiment, n=1 distraction) have completed all eight IVR sessions. Preliminary results indicate a decrease from pre to post-intervention in Numerical Pain Rating Scale score (pre: 5/10, 6/10, 5/10; post: 2/10, 5/10, 2/10) and Pain Catastrophising Scale score (pre: 34/52, 11/52, 38/52; post: 11/52, 8/52, 12/52), with no clear trend in other self-reported measures (Hospital Anxiety and Depression scale, Oswestry low back disability questionnaire, fear-avoidance beliefs questionnaire, Tampa scale of kinesiophobia). Preliminary results suggest a potential increase in NPRS absolute values from pre- to post-intervention in CPM (pre: -2.7, -2.3, -2.0; post: -3.3, -2.0, -4.3) and TS (pre-1.2, 2.5, 2.4; post: 1.4, 2.5, 3.1). Conclusion. Eight sessions of IVR may reduce pain severity and pain catastrophising in people with PLBP and may increase the efficacy of endogenous pain modulatory systems. Data collection is ongoing to compare the effect of distraction- and embodiment-based IVR. Conflicts of Interest. There are no conflicts of interest. Sources of Funding. This project is funded by the Saudi Arabia Cultural Bureau