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

Aims. In a multicentre, randomised study of adolescents undergoing posterior spinal fusion for idiopathic scoliosis, we investigated the effect of adding gelatine matrix with human thrombin to the standard surgical methods of controlling blood loss. Patients and Methods. Patients in the intervention group (n = 30) were randomised to receive a minimum of two and a maximum of four units of gelatine matrix with thrombin in addition to conventional surgical methods of achieving haemostasis. Only conventional surgical methods were used in the control group (n = 30). We measured the intra-operative and total blood loss (intra-operative blood loss plus post-operative drain output). Results. Each additional hour of operating time increased the intra-operative blood loss by 356.9 ml (p < 0.001) and the total blood loss by 430.5 ml (p < 0.001). Multiple linear regression analysis showed that the intervention significantly decreased the intra-operative (-171 ml, p = 0.025) and total blood loss (-177 ml, p = 0.027). The decrease in haemoglobin concentration from the day before the operation to the second post-operative day was significantly smaller in the intervention group (-6 g/l, p = 0.013) than in the control group. . Conclusion. The addition of gelatine matrix with human thrombin to conventional methods of achieving haemostasis reduces both the intra-operative blood loss and the decrease in haemoglobin concentration post-operatively in adolescents undergoing posterior spinal fusion for idiopathic scoliosis. Take home message: A randomised clinical trial showed that gelatine matrix with human thrombin decreases intra-operative blood loss by 30% when added to traditional surgical haemostatic methods in adolescents undergoing posterior spinal fusion for idiopathic scoliosis. Cite this article: Bone Joint J 2016;98-B:395–401

The National Institute for Health and Care Excellence has issued guidelines that state fusion for non-specific low back pain should only be performed as part of a randomised controlled trial, and that lumbar disc replacement should not be performed. Thus, spinal fusion and disc replacement will no longer be routine forms of treatment for patients with low back pain. This annotation considers the evidence upon which these guidelines are based. Cite this article: Bone Joint J 2017;99-B:1003–1005

Aims. We compared the clinical and radiological outcomes of using a polyetheretherketone cage with (TiPEEK) and without a titanium coating (PEEK) for instrumented transforaminal lumbar interbody fusion (TLIF). Materials and Methods. We conducted a randomised clinical pilot trial of 40 patients who were scheduled to undergo a TLIF procedure at one or two levels between L2 and L5. The Oswestry disability index (ODI), EuroQoL-5D, and back and leg pain were determined pre-operatively, and at three, six, and 12 months post-operatively. Fusion rates were assessed by thin slice CT at three months and by functional radiography at 12 months. Results. At final follow-up, one patient in each group had been lost to follow-up. Two patients in each of the PEEK and TiPEEK groups were revised for pseudarthrosis (p = 1.00). The rate of complete or partial fusion at three months was 91.7% in both groups. Overall, there were no significant differences in ODI or in radiological outcomes between the groups. Conclusion. Favourable results with identical clinical outcomes and a high rate of fusion was seen in both groups. The titanium coating appears to have no negative effects on outcome or safety in the short term. A future study to determine the effect of titanium coating is warranted. Cite this article: Bone Joint J 2017;99-B:1366–72

This is a prospective randomised study comparing the clinical and radiological outcomes of uni- and bipedicular balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. A total of 44 patients were randomised to undergo either uni- or bipedicular balloon kyphoplasty. Self-reported clinical assessment using the Oswestry Disability Index, the Roland-Morris Disability questionnaire and a visual analogue score for pain was undertaken pre-operatively, and at three and twelve months post-operatively. The vertebral height and kyphotic angle were measured from pre- and post-operative radiographs. Total operating time and the incidence of cement leakage was recorded for each group. Both uni- and bipedicular kyphoplasty groups showed significant within-group improvements in all clinical outcomes at three months and twelve months after surgery. However, there were no significant differences between the groups in all clinical and radiological outcomes. Operating time was longer in the bipedicular group (p < 0.001). The incidence of cement leakage was not significantly different in the two groups (p = 0.09). A unipedicular technique yielded similar clinical and radiological outcomes as bipedicular balloon kyphoplasty, while reducing the length of the operation. We therefore encourage the use of a unipedicular approach as the preferred surgical technique for the treatment of osteoporotic vertebral compression fractures. Cite this article: Bone Joint J 2013;95-B:401–6

Aims. The aim of this study was to compare the effect of a percutaneous radiofrequency heat lesion at the medial branch of the primary dorsal ramus with a sham procedure, for the treatment of lumbar facet joint pain. Patients and Methods. A randomised sham-controlled double blind multicentre trial was carried out at the multidisciplinary pain centres of two hospitals. A total of 60 patients aged > 18 years with a history and physical examination suggestive of facet joint pain and a decrease of ≥ 2 on a numerical rating scale (NRS 0 to 10) after a diagnostic facet joint test block were included. In the treatment group, a percutaneous radiofrequency heat lesion (80. o. C during 60 seconds per level) was applied to the medial branch of the primary dorsal ramus. In the sham group, the same procedure was undertaken without for the radiofrequency lesion. Both groups also received a graded activity physiotherapy programme. The primary outcome measure was decrease in pain. A secondary outcome measure was the Global Perceived Effect scale (GPE). Results. There was a statistically significant effect on the level of pain in the factor Period (T0-T1). However, there was no statistically significant difference with the passage of time between the groups (Group × Period) or in the factor Group. In the crossover group, 11 of 19 patients had a decrease in NRS of ≥ 2 at one month crossover (p = 0.65). There was no statistically significant difference in satisfaction with the passage of time between the groups (Group × Period). The independent factors Group and Period also showed no statistically significant difference. There was no statistically significant Group × Period effect for recovery, neither an effect of Group or of Period. Conclusion. The null hypothesis of no difference in the decrease in pain and in GPE between the treatment and sham groups cannot be rejected. Post hoc analysis revealed that the age of the patients and the severity of the initial pain significantly predicted a positive outcome. Cite this article: Bone Joint J 2016;98-B:1526–33

Aims. In order to evaluate the effectiveness of the Mobi-C implant in cervical disc degeneration, a randomised study was conducted, comparing the Mobi-C prosthesis arthroplasty with anterior cervical disc fusion (ACDF) in patients with single level cervical spondylosis. Patients and Methods. From January 2008 to July 2009, 99 patients were enrolled and randomly divided into two groups, those having a Mobi-C implant (n = 51; 30 men, 21 women) and those undergoing ACDF (n = 48; 28 men, 20 women).The patients were followed up for five years, with the primary outcomes being the Japanese Orthopaedic Association score, visual analogue scale for pain and the incidence of further surgery. The secondary outcomes were the Neck Disability Index and range of movement (ROM) of the treated segment. Results. The incidence of further surgery was found to be statistically significant between the two groups (p = 0.49), with seven ACDF patients requiring further surgery and only one Mobi-C patient requiring re-operation. There were significant differences (p < 0.001) between the two groups in the ROM of the treated segment. However, both Mobi-C surgery and ACDF surgery were effective in improving the patient’s clinical symptoms. Take home message: Mobi-C implant surgery is a safe alternative to ACDF surgery in cervical disc degeneration. Cite this article: Bone Joint J 2016;98-B:829–3

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

Vertebral compression fractures are the most prevalent complication of osteoporosis and percutaneous vertebroplasty (PVP) has emerged as a promising addition to the methods of treating the debilitating pain they may cause. Since PVP was first reported in the literature in 1987, more than 600 clinical papers have been published on the subject. Most report excellent improvements in pain relief and quality of life. However, these papers have been based mostly on uncontrolled cohort studies with a wide variety of inclusion and exclusion criteria. In 2009, two high-profile randomised controlled trials were published in the New England Journal of Medicine which led care providers throughout the world to question the value of PVP. After more than two decades a number of important questions about the mechanism and the effectiveness of this procedure remain unanswered

This prospective multicentre study was undertaken to determine segmental movement, disc height and sagittal alignment after total disc replacement (TDR) in the lumbosacral spine and to assess the correlation of biomechanical properties to clinical outcomes. A total of 173 patients with degenerative disc disease and low back pain for more than one year were randomised to receive either TDR or multidisciplinary rehabilitation (MDR). Segmental movement in the sagittal plane and disc height were measured using distortion compensated roentgen analysis (DCRA) comparing radiographs in active flexion and extension. Correlation analysis between the range of movement or disc height and patient-reported outcomes was performed in both groups. After two years, no significant change in movement in the sagittal plane was found in segments with TDR or between the two treatment groups. It remained the same or increased slightly in untreated segments in the TDR group and in this group there was a significant increase in disc height in the operated segments. There was no correlation between segmental movement or disc height and patient-reported outcomes in either group. In this study, insertion of an intervertebral disc prosthesis TDR did not increase movement in the sagittal plane and segmental movement did not correlate with patient-reported outcomes. This suggests that in the lumbar spine the movement preserving properties of TDR are not major determinants of clinical outcomes. Cite this article: Bone Joint J 2013;95-B:81–9

We have assessed whether an epidural steroid injection is effective in the treatment of symptoms due to compression of a nerve root in the lumbar spine by carrying out a prospective, randomised, controlled trial in which patients received either an epidural steroid injection or an intramuscular injection of local anaesthetic and steroid. We assessed a total of 93 patients according to the Oxford pain chart and the Oswestry disability index and followed up for a minimum of two years. All the patients had been categorised as potential candidates for surgery. There was a significant reduction in pain early on in those having an epidural steroid injection but no difference in the long term between the two groups. The rate of subsequent operation in the groups was similar

Antibiotics are often administrated prophylactically in spinal procedures to reduce the risk of infection of the disc space. It is still not known which antibiotics are able to penetrate the intervertebral disc effectively. In a prospective, randomised, double-blind clinical study, we examined the penetration of the intervertebral discs of two commonly used antibiotics, cefuroxime and gentamicin. The patients, randomised into two groups, received either 1.5 g of cefuroxime or 5 mg/kg of gentamicin prophylactically two hours before their intervertebral discs were removed. A specimen of blood, from which serum antibiotic levels were determined, was obtained at the time of discectomy. Therapeutic levels of antibiotic were detectable in the intervertebral discs of the ten patients who received gentamicin. Only two of the ten patients (20%) who received cefuroxime had a quantifiable level of antibiotic in their discs although therapeutic serum levels of cefuroxime were found in all ten patients. Our results show that cefuroxime does not diffuse into human intervertebral discs as readily as gentamicin. It is possible that the charge due to ionisable groups on the antibiotics can influence the penetration of the antibiotics. We therefore recommend the use of gentamicin in a single prophylactic dose for all spinal procedures in order to reduce the risk of discitis

Between March 2000 and February 2006, we carried out a prospective study of 100 patients with a low-grade isthmic spondylolisthesis (Meyerding grade II or below), who were randomised to receive a single-level and instrumented posterior lumbar interbody fusion with either one or two cages. The minimum follow-up was for two years. At this stage 91 patients were available for review. A total of 47 patients received one cage (group 1) and 44 two cages (group 2). The clinical and radiological outcomes of the two groups were compared. There were no significant differences between the two groups in terms of post-operative pain, Oswestry Disability Score, clinical results, complication rate, percentage of post-operative slip, anterior fusion rate or posterior fusion rate. On the other hand, the mean operating time was 144 minutes (100 to 240) for patients in group 1 and 167 minutes (110 to 270) for those in group 2 (p = 0.0002). The mean blood loss up to the end of the first post-operative day was 756 ml (510 to 1440) in group 1 and 817 ml (620 to 1730) in group 2 (p < 0.0001). Our results suggest that an instrumented posterior lumbar interbody fusion performed with either one or two cages in addition to a bone graft around the cage has a low rate of complications and a high fusion rate. The clinical outcomes were good in most cases, regardless of whether one or two cages had been used

We conducted a prospective, randomised study of 42 cervical interbody fusions undertaken with either an autologous tricortical graft or a cage. The factors assessed in the two groups were: (1) time taken to achieve fusion; (2) neck disability index; (3) pain score; (4) interbody height ratio; (5) interbody angle and (6) the influence of smoking on fusion. No statistical difference was seen in the time taken to achieve fusion, neck disability index, interbody height ratio, or interbody angles. Smoking did not have any effect on the fusion process. The pain score was significantly lower in the tricortical graft group at six months. We conclude that both methods of fusion give similar results, although tricortical graft fusion is cheaper than cage fusion, and is more effective in reducing the pain score

We performed a randomised, controlled clinical trial to compare ambulant short-course chemotherapy with anterior spinal fusion plus short-course chemotherapy for spinal tuberculosis without paraplegia. Patients with active disease of vertebral bodies were randomly allocated to one of three regimens: a) radical anterior resection with bone grafting plus six months of daily isoniazid plus rifampicin (Rad6); b) ambulant chemotherapy for six months with daily isoniazid plus rifampicin (Amb6); or c) similar to b) but with chemotherapy for nine months (Amb9). Ten years from the onset of treatment, 90% of 78 Rad6, 94% of 78 Amb6 and 99% of 79 Amb9 patients had a favourable status. Ambulant chemotherapy for a period of six months with daily isoniazid plus rifampicin (Amb6) was an effective treatment for spinal tuberculosis except in patients aged less than 15 years with an initial angle of kyphosis of more than 30° whose kyphosis increased substantially

In order to determine the influence of early ambulation and other factors on headaches occurring after lumbar myelography we randomised 207 patients (127 men and 80 women) into two groups. Following the investigation, we allowed the 101 patients (65 men and 36 women) in group A to sit or stand freely, while we confined the 106 patients (62 men and 44 women) in group B to bed for 20 hours. The nine patients in group B who could not maintain bed rest were excluded. There was no significant difference between the two groups as regards the prevalence of spinal headache (8.9% in group A v 14.4% in group B). Patients who reported headaches, however, were significantly more likely to be women (18.7%) than men (7.3%), be younger (mean age 45 years v 56 years), have a higher cerebrospinal pressure before removal of fluid (mean values 172 v 137 mm H. 2. O) and a lower systolic (mean values 120 v 134 mmHg) and diastolic blood pressure. We conclude that, although other factors may be associated with headaches, late ambulation is not effective in preventing spinal headaches after lumbar myelography

We have evaluated the use of a synthetic porous ceramic (Triosite) as a substitute for bone graft in posterior spinal fusion for idiopathic scoliosis. In a prospective, randomised study 341 patients at five hospitals in the UK and France were randomly allocated either to autograft from the iliac crest or rib segments (171) or to receive Triosite blocks (170). All patients were assessed after operation and at 3, 6, 12 and 18 months. The two groups were similar with regard to all demographic and baseline variables, but the 184 treated in France (54%) had Cotrel-Dubouset instrumentation and the 157 treated in the UK usually had Harrington-Luque implants. In the Triosite group the average Cobb angle of the upper curve was 56°, corrected to 24° (57%). At 18 months, the average was 26° (3% loss). In the autograft group the average preoperative upper curve of 53° was corrected to 21° (60%). At 18 months the mean curve was 25° (8% loss). Pain levels after operation were similar in the two groups, being mild in most cases. In the Triosite group only three patients had problems of wound healing, but in the autograft group, 14 patients had delayed healing, infection or haematoma in the spinal wound. In addition, 15 autograft patients had pain at the donor site at three months. Seven had infections, two had haematoma and four had delayed healing. The haematological and serum biochemistry results showed no abnormal trends and no significant differences between the groups. There were no adverse events related to the graft material and no evidence of allergenicity. Our results suggest that Triosite synthetic porous ceramic is a safe and effective substitute for autograft in these patients. Histological findings on biopsy indicate that Triosite provides a favourable scaffolding for the formation of new bone and is gradually incorporated into the fusion mass

Aims

The aim of this study was to determine whether the sequential application of povidone iodine-alcohol (PVI) followed by chlorhexidine gluconate-alcohol (CHG) would reduce surgical wound contamination to a greater extent than PVI applied twice in patients undergoing spinal surgery.

Aims

Our aim was to perform a systematic review of the literature to assess the incidence of post-operative epidural haematomas and wound infections after one-, or two-level, non-complex, lumbar surgery for degenerative disease in patients with, or without post-operative wound drainage.

Aims

To evaluate the incidence of primary venous thromboembolism (VTE), epidural haematoma, surgical site infection (SSI), and 90-day mortality after elective spinal surgery, and the effect of two protocols for prophylaxis.