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

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.

Aims. The aim of this study was to evaluate whether, after correction of an adolescent idiopathic scoliosis (AIS), leaving out the subfascial drain gives results that are no worse than using a drain in terms of total blood loss, drop in haemoglobin level, and opioid consumption. Methods. Adolescents (aged between 10 and 21 years) with an idiopathic scoliosis (major curve ≥ 45°) were eligible for inclusion in this randomized controlled noninferiority trial (n = 125). A total of 90 adolescents who had undergone segmental pedicle screw instrumentation were randomized into no-drain or drain groups at the time of wound closure using the sealed envelope technique (1:1). The primary outcome was a drop in the haemoglobin level during first three postoperative days. Secondary outcomes were 48-hour postoperative oxycodone consumption and surgical complications. Results. All 90 patients were included in the primary outcome analysis (no drain = 43; drain = 47). The mean total postoperative blood loss (intraoperative and drain output) was significantly higher in the group with a subfascial drain than in the no-drain group (1,008 ml (SD 520) vs 631 ml (SD 518); p < 0.001). The drop in haemoglobin level did not differ between the study groups over the postoperative timepoints (p = 0.290). The 48-hour opioid consumption was significantly higher in the no-drain group (2.0 mg/kg (SD 0.9) vs 1.4 (SD 0.6); p = 0.005). Two patients in the no-drain and one patient in the drain group developed a surgical site infection. Conclusion. Leaving the subfascial drain out after pedicle screw instrumentation for AIS is not associated with higher postoperative haemoglobin levels. Patients treated without a subfascial drain needed 30% more opioids during the first 48 hours than those who had a drain. Cite this article: Bone Joint J 2022;104-B(9):1067–1072

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. Results. Five-year follow-up was completed by 213 (95%) of the eligible patients (mean age 67 years; 155 female (67%)). After five years, ODI was similar irrespective of treatment, with a mean of 25 (SD 18) for decompression alone and 28 (SD 22) for decompression with fusion (p = 0.226). Mean EQ-5D was higher for decompression alone than for fusion (0.69 (SD 0.28) vs 0.59 (SD 0.34); p = 0.027). In the no-DS subset, fewer patients reported decreased leg pain after fusion (58%) than with decompression alone (80%) (relative risk (RR) 0.71 (95% confidence interval (CI) 0.53 to 0.97). The frequency of subsequent spinal surgery was 24% for decompression with fusion and 22% for decompression alone (RR 1.1 (95% CI 0.69 to 1.8)). Conclusion. Adding fusion to decompression in spinal stenosis surgery, with or without spondylolisthesis, does not improve the five-year ODI, which is consistent with our two-year report. Three secondary outcomes that did not differ at two years favoured decompression alone at five years. Our results support decompression alone as the preferred method for operating on spinal stenosis. Cite this article: Bone Joint J 2024;106-B(7):705–712

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.

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. Methods. As part of the SpInOuT-F study, a pilot randomized trial was carried out across five NHS hospitals. Patients were randomized to either spinal decompression alone or spinal decompression plus instrumented fusion. Patient-reported outcome measures were collected at baseline and three months. The intended sample size was 60 patients. Results. Of the 90 patients screened, 77 passed the initial screening criteria. A total of 27 patients had a PI-LL mismatch and 23 had a dynamic spondylolisthesis. Following secondary inclusion and exclusion criteria, 31 patients were eligible for the study. Six patients were randomized and one underwent surgery during the study period. Given the low number of patients recruited and randomized, it was not possible to assess completion rates, quality of life, imaging, or health economic outcomes as intended. Conclusion. This study provides a unique insight into the prevalence of dynamic spondylolisthesis and PI-LL mismatch in patients with symptomatic spinal stenosis, and demonstrates that there is a need for a definitive RCT which stratifies for these groups in order to inform surgical decision-making. Nonetheless a definitive study would need further refinement in design and implementation in order to be feasible. Cite this article: Bone Jt Open 2023;4(8):573–579

Aims. The aim of this study was to systematically compare the safety and accuracy of robot-assisted (RA) technique with conventional freehand with/without fluoroscopy-assisted (CT) pedicle screw insertion for spine disease. Methods. A systematic search was performed on PubMed, EMBASE, the Cochrane Library, MEDLINE, China National Knowledge Infrastructure (CNKI), and WANFANG for randomized controlled trials (RCTs) that investigated the safety and accuracy of RA compared with conventional freehand with/without fluoroscopy-assisted pedicle screw insertion for spine disease from 2012 to 2019. This meta-analysis used Mantel-Haenszel or inverse variance method with mixed-effects model for heterogeneity, calculating the odds ratio (OR), mean difference (MD), standardized mean difference (SMD), and 95% confidence intervals (CIs). The results of heterogeneity, subgroup analysis, and risk of bias were analyzed. Results. Ten RCTs with 713 patients and 3,331 pedicle screws were included. Compared with CT, the accuracy rate of RA was superior in Grade A with statistical significance and Grade A + B without statistical significance. Compared with CT, the operating time of RA was longer. The difference between RA and CT was statistically significant in radiation dose. Proximal facet joint violation occurred less in RA than in CT. The postoperative Oswestry Disability Index (ODI) of RA was smaller than that of CT, and there were some interesting outcomes in our subgroup analysis. Conclusion. RA technique could be viewed as an accurate and safe pedicle screw implantation method compared to CT. A robotic system equipped with optical intraoperative navigation is superior to CT in accuracy. RA pedicle screw insertion can improve accuracy and maintain stability for some challenging areas. Cite this article: Bone Joint Res 2020;9(10):653–666

Introduction. The PACE trial was the first randomized controlled trial (RCT) investigating the efficacy of paracetamol in acute low back pain. Non-compliance to study medication was considered to be a limitation of this RCT. In contrast to conventional statistical methods, complier average causal effects (CACE) analysis may provide unbiased estimates of the effects for participants compliant to paracetamol. Methods. Intention to treat (ITT), as-treated, propensity weighted CACE and joint modeling CACE estimates were calculated for pain intensity, disability, global perceived effect and function at two weeks of follow up with compliance defined as an average of at least four tablets per day during the first two weeks of the trial. For pain intensity, exploratory analyses were conducted using additional time points and definitions of compliance. Results. 547 participants had been randomized to placebo and 550 to regular paracetamol; of the latter group, 72% of patients was classified as compliers. Mean differences in pain intensity between paracetamol and placebo using the main time point and definition of compliance were non-significant (ITT 0.11, p = 0.49; as-treated 0.29, p = 0.12; propensity weighed CACE −0.12, p = 0.51; joint modeling CACE 0.28, p = 0.13); similar results were obtained for disability, global perceived effect and function and for additional time points and definitions of compliance. Conclusion. In compliers, paracetamol had no significant effect on pain intensity when compared to placebo; this supports the conclusions from the original analysis. However, these calculations are based on patient-reported compliance, which may not perfectly represent actual medication consumption. Conflicts of interest: AM has received funding for a postgraduate research scholarship from GlaxoSmithKline. CM has received funding to review teaching materials prepared by GlaxoSmithKline. The other authors declare no competing interests. Sources of funding: The PACE trial was an investigator-initiated study funded by a project grant from National Health and Medical Research Council of Australia. GlaxoSmithKline Australia provided subsequent supplementary funding and the paracetamol and matched placebo. CM is supported by Australian Research Council Future Fellowships FT-100100603. CL is supported by a Career Development Fellowship from the National Health and Medical Research Council, Australia (APP1061400). This secondary analysis of the PACE data has been supported by a program grant of the Dutch Arthritis Foundation and by the Foundation “De Drie Lichten” in The Netherlands

To evaluate the current biomechanical and clinical evidence available on the use and effectiveness of lumbar interspinous devices. Literature review. A PubMed search was done using the following key words: interspinous implants, interspinous devices, interspinous spacers, dynamic stabilization, X-stop, Coflex, Wallis, DIAM. The abstracts of all the articles were reviewed. Further critical analysis was done of the relevant articles. Special emphasis was given to those articles pertaining to biomechanical and clinical results. A total of 50 articles were found, 18 of them also related to the effect of spacers on the biomechanics of the spine. 25 articles were on the X-stop device. However, level I evidence is lacking. Only two prospective randomized controlled trials have been done and these were on the X-Stop device. Analysis of current evidence suggests a potential beneficial effect of lumbar interspinous spacers in select group of patients. However, further level I evidence is required to justify their widespread use for all the proposed indications. The results of the ongoing trials are keenly awaited

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).

Aims

Closed suction subfascial drainage is widely used after instrumented posterior spinal fusion in patients with a spinal deformity. The aim of this study was to determine the effect of this wound drainage on the outcomes in patients with adolescent idiopathic scoliosis (AIS). This was a further analysis of a randomized, multicentre clinical trial reporting on patients after posterior spinal fusion using segmental pedicle screw instrumentation. In this study the incidence of deep surgical site infection (SSI) and chronic postoperative pain at two years’ follow-up are reported.

Aims

This systematic review aims to identify 3D predictors derived from biplanar reconstruction, and to describe current methods for improving curve prediction in patients with mild adolescent idiopathic scoliosis.

Study design. Literature review of the best available evidence on the accuracy of computer assisted pedicle screw insertion. Background. Pedicle screw misplacement rates with the conventional insertion technique and adequate postoperative CT examination have ranged from 5 to 29 % in the cervical spine, from 3 to 58 % in the thoracic spine, and from 6 to 41% in the lumbosacral region. Despite these relatively high perforation rates, the incidence of reported screw-related complications has remained low. Interestingly, the highest rates of neurovascular injuries have been reported from the lumbosacral spine in up to 17% of the patients. Gertzbein and Robbins introduced a 4-mm “safe zone” in the thoracolumbar spine for medial encroachment, consisting of 2-mm of epidural and 2-mm of subarachnoid space. Later, several authors have found the safety margins to be significantly smaller, suggesting that the “safe zone” thresholds of Gertzbein and Robbins do not apply to the thoracic spine, and seem to be too high even for the lumbar spine. The midthoracic and midcervical spine, as well as the thoracolumbar junction set the highest demands for accuracy in pedicle screw insertion, with no room for either translational or rotational error at e.g. T5 level. Computer assisted pedicle screw insertion (navigation) was introduced in the early 90's to increase the accuracy and safety of pedicle screw insertion. Material. PubMed literature search revealed two randomized controlled trials (RCT) comparing the in vivo accuracy of conventional and computer assisted pedicle screw insertion techniques. Three meta-analyses have assessed the published reports on the accuracy of pedicle screw insertion with or without computer assistance, one additional meta-analysis concentrated on the functional outcome of computer assisted pedicle screw insertion. Results. The RCTs by Laine et al and Rajasekaran et al achieved significantly higher screw placement accuracy with computer assistance than with the conventional techniquebased on anatomical landmarks. In a degenerative patient population, Laine et al reported a misplacement rate of 4.6% with computer assistance compared to 13.4% with the conventional technique. In addition to this quantitative difference, a qualitative difference in the misplaced screws was noticed: in the conventional group, 28 out of 37 misplaced screws were either inferior or medial, whereas in the computer assisted group, 1 out of 10 misplaced screws was situated in these ”danger zones”. In deformity surgery, Rajasekaran et al reported a 2% pedicle screw misplacement rate with a computer assisted technique compared to 23% with the conventional technique. Interestingly, in their study, the average screw insertion time in the computer assisted group was significantly shorter than with the conventional technique. The three meta-analyses, assessing up to 37 337 pedicle screws, reported significantly higher accuracy in the placement of pedicle screws with computerassistance compared with the conventional methods. The superiority of the computer assisted technique was even more obvious with abnormal surgical anatomy. CT-based and 3D-fluoroscopy-based navigation methods provided better accuracy compared to 2Dfluoroscopy-based navigation. No statistically significant benefit with computer assistance in the incidence of neuro-vascular complications, or in functional outcome was demonstrated. Conclusion. High pedicle screw misplacement rates have been reported with the conventional technique based on anatomical landmarks and intraoperative fluoroscopy. The concept of ”safe zone” is hypothetical, and underestimates the true risks of misplaced pedicle screws. Computer assistance significantly improves the accuracy and safety of pedicle screw insertion. It will, however, be difficult to correlate this increased accuracy to improved patient outcomes

Aims

The aim of this study was to determine whether early surgical treatment results in better neurological recovery 12 months after injury than late surgical treatment in patients with acute traumatic spinal cord injury (tSCI).

This review provides a concise outline of the advances made in the care of patients and to the quality of life after a traumatic spinal cord injury (SCI) over the last century. Despite these improvements reversal of the neurological injury is not yet possible. Instead, current treatment is limited to providing symptomatic relief, avoiding secondary insults and preventing additional sequelae. However, with an ever-advancing technology and deeper understanding of the damaged spinal cord, this appears increasingly conceivable. A brief synopsis of the most prominent challenges facing both clinicians and research scientists in developing functional treatments for a progressively complex injury are presented. Moreover, the multiple mechanisms by which damage propagates many months after the original injury requires a multifaceted approach to ameliorate the human spinal cord. We discuss potential methods to protect the spinal cord from damage, and to manipulate the inherent inhibition of the spinal cord to regeneration and repair. Although acute and chronic SCI share common final pathways resulting in cell death and neurological deficits, the underlying putative mechanisms of chronic SCI and the treatments are not covered in this review.

Aims

Vertebral body tethering (VBT) is a non-fusion technique to correct scoliosis. It allows correction of scoliosis through growth modulation (GM) by tethering the convex side to allow concave unrestricted growth similar to the hemiepiphysiodesis concept. The other modality is anterior scoliosis correction (ASC) where the tether is able to perform most of the correction immediately where limited growth is expected.

Aims

To determine the effectiveness of prone traction radiographs in predicting postoperative slip distance, slip angle, changes in disc height, and lordosis after surgery for degenerative spondylolisthesis of the lumbar spine.

Aims

Chronic low back pain due to degenerative disc disease is sometimes treated with fusion. We compared the outcome of three different fusion techniques in the Swedish Spine Register: noninstrumented posterolateral fusion (PLF), instrumented posterolateral fusion (IPLF), and interbody fusion (IBF).

Aims

Spinal tuberculosis (TB) remains an important concern. Although spinal TB often has sequelae such as myelopathy after treatment, the predictive factors affecting such unfavourable outcomes are not yet established. We investigated the clinical manifestations and predictors of unfavourable treatment outcomes in patients with spinal TB.

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.