Bracing Adolescent Idiopathic Scoliosis (BASIS) study - night-time versus full-time bracing in adolescent idiopathic scoliosis: study protocol for a multicentre, randomized controlled trial.

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.

Cauda equina syndrome.

Aims: Patients with cauda equina syndrome (CES) require emergency imaging and surgical decompression. The severity and type of symptoms may influence the timing of imaging and surgery, and help predict the patient's prognosis. Categories of CES attempt to group patients for management and prognostication purposes. We aimed in this study to assess the inter-rater reliability of dividing patients with CES into categories to assess whether they can be reliably applied in clinical practice and in research. Methods: A literature review was undertaken to identify published descriptions of categories of CES. A total of 100 real anonymized clinical vignettes of patients diagnosed with CES from the Understanding Cauda Equina Syndrome (UCES) study were reviewed by consultant spinal surgeons, neurosurgical registrars, and medical students. All were provided with published category definitions and asked to decide whether each patient had 'suspected CES'; 'early CES'; 'incomplete CES'; or 'CES with urinary retention'. Inter-rater agreement was assessed for all categories, for all raters, and for each group of raters using Fleiss's kappa. Results: Each of the 100 participants were rated by four medical students, five neurosurgical registrars, and four consultant spinal surgeons. No groups achieved reasonable inter-rater agreement for any of the categories. CES with retention versus all other categories had the highest inter-rater agreement (kappa 0.34 (95% confidence interval 0.27 to 0.31); minimal agreement). There was no improvement in inter-rater agreement with clinical experience. Across all categories, registrars agreed with each other most often (kappa 0.41), followed by medical students (kappa 0.39). Consultant spinal surgeons had the lowest inter-rater agreement (kappa 0.17). Conclusion: Inter-rater agreement for categorizing CES is low among clinicians who regularly manage these patients. CES categories should be used with caution in clinical practice and research studies, as groups may be heterogenous and not comparable.

Presentation, management, and outcomes of cauda equina syndrome up to one year after surgery, using clinician and participant reporting: A multi-centre prospective cohort study.

Background: Cauda equina syndrome (CES) results from nerve root compression in the lumbosacral spine, usually due to a prolapsed intervertebral disc. Evidence for management of CES is limited by its infrequent occurrence and lack of standardised clinical definitions and outcome measures. Methods: This is a prospective multi-centre observational cohort study of adults with CES in the UK. We assessed presentation, investigation, management, and all Core Outcome Set domains up to one year post-operatively using clinician and participant reporting. Univariable and multivariable associations with the Oswestry Disability Index (ODI) and urinary outcomes were investigated. Findings: In 621 participants with CES, catheterisation for urinary retention was required pre-operatively in 31% (191/615). At discharge, only 13% (78/616) required a catheter. Median time to surgery from symptom onset was 3 days (IQR:1-8) with 32% (175/545) undergoing surgery within 48 h. Earlier surgery was associated with catheterisation (OR:2.2, 95%CI:1.5-3.3) but not with admission ODI or radiological compression. In multivariable analyses catheter requirement at discharge was associated with pre-operative catheterisation (OR:10.6, 95%CI:5.8-20.4) and one-year ODI was associated with presentation ODI (r = 0.3, 95%CI:0.2-0.4), but neither outcome was associated with time to surgery or radiological compression. Additional healthcare services were required by 65% (320/490) during one year follow up. Interpretation: Post-operative functional improvement occurred even in those presenting with urinary retention. There was no association between outcomes and time to surgery in this observational study. Significant healthcare needs remained post-operatively. Funding: DCN Endowment Fund funded study administration. Castor EDC provided database use. No other study funding was received.

Study protocol for a randomised controlled trial of consenting processes and their effects on patient decision-making when undergoing spinal injections: the Risks In Spinal Consenting for Surgery (RISCS) trial.

INTRODUCTION: There are major differences between legal and medical approaches to informed consent. Medically, consent is obtained prospectively for an intended procedure, to inform the patient of choices, risks and benefits, and to manage expectations. Legally, consent is reviewed retrospectively, usually following unmet expectations and/or the occurrence of complications. Recent legal cases relating to clinical negligence define the establishment of causation and breach of duty related to informed consent. However, there is no prospective evidence to validate the current judicial perspectives on causation and thus clinical negligence. The aim of this randomised controlled trial (RCT) is to investigate whether variations in consenting processes for the same procedure lead to changes in patient decision-making related to consent for that procedure. METHODS AND ANALYSIS: The Risks In Spinal Consenting for Surgery trial is a single-centre, non-inferiority RCT, where 220 patients, aged over 18 years, receiving an elective, day case spinal injection, will be randomised to either a 'legally styled' consent form with 55 risks identified in the world literature, or a 'medically styled' consent form with the 13 serious or most common risks usually quoted by reference to specialist society guidelines. Following explanation of the medical reasons for considering an injection therapy and consent to the trial, participants will be randomly allocated to one of two groups (1:1). The patients are then given the opportunity to discuss any concerns relating to the procedure and/or risks with a single specialist practitioner. The primary outcome will be rates of consent withdrawal due to the risks explained. Secondary outcomes include scores from the State-Trait Anxiety Inventory, Visual Analogue Scale, EuroQol 5-dimension questionnaire and Oswestry Disability Index. ETHICS AND DISSEMINATION: Results will be presented in peer-reviewed journals and at international conferences. This study is approved by the Health Research Authority: REC 16/SC/0510. TRIAL REGISTRATION NUMBER: ISRCTN67513618; Pre-results.

Caution: laparoscopic biopsy of a large pelvic mass may result in disaster.

Anterior sacral meningocele is a rare cause of a pelvic mass. Herein the authors describe the case of a young patient presenting with chronic pelvic pain undergoing diagnostic laparoscopy. She was found to have a retrorectal mass confirmed as an anterior sacral meningocele on subsequent MRI. The authors explore the case, describe a method of intraoperative management to minimize the risk of severe complications and include a discussion of the differential diagnosis. Central to this is an emphasis on advocating a cautious approach when confronted with an incidental unknown pelvic mass, as deleterious consequences may occur from biopsy of such a lesion.

Avulsion of the perforating branch of the peroneal artery secondary to an ankle sprain: a cause of acute compartment syndrome in the leg.

In this report, we describe the case of an adult male who developed an acute compartment syndrome localized to the anterior compartment of the leg following an ankle sprain. Compartment syndrome in association with ankle sprain is unusual, and has been previously described in association with avulsion of the perforating peroneal artery. Because of the potential for severe morbidity, we feel that it is important to make foot and ankle surgeons aware of this unusual injury.

The use of physical biomodelling in complex spinal surgery.

Prior studies have suggested that biomodels enhance patient education, preoperative planning and intra-operative stereotaxy; however, the usefulness of biomodels compared to regular imaging modalities such as X-ray, CT and MR has not been quantified. Our objective was to quantify the surgeon's perceptions on the usefulness of biomodels compared to standard visualisation modalities for preoperative planning and intra-operative anatomical reference. Physical biomodels were manufactured for a series of 26 consecutive patients with complex spinal pathologies using a stereolithographic technique based on CT data. The biomodels were used preoperatively for surgical planning and customising implants, and intra-operatively for anatomical reference. Following surgery, a detailed biomodel utility survey was completed by the surgeons, and informal telephone interviews were conducted with patients. Using biomodels, 21 deformity and 5 tumour cases were performed. Surgeons stated that the anatomical details were better visible on the biomodel than on other imaging modalities in 65% of cases, and exclusively visible on the biomodel in 11% of cases. Preoperative use of the biomodel led to a different decision regarding the choice of osteosynthetic materials used in 52% of cases, and the implantation site of osteosynthetic material in 74% of cases. Surgeons reported that the use of biomodels reduced operating time by a mean of 8% in tumour patients and 22% in deformity procedures. This study supports biomodelling as a useful, and sometimes essential tool in the armamentarium of imaging techniques used for complex spinal surgery.

In vivo temperature profile of intervertebral discs and vertebral endplates during vertebroplasty: an experimental study in sheep.

STUDY DESIGN: Experimental study of temperature profiles during vertebroplasty. OBJECTIVES: To define accurate temperature profiles during vertebroplasty in an in vivo animal model. SUMMARY OF BACKGROUND DATA: Controversy still exists whether vertebroplasty achieves its analgesic effect by stabilizing fracture fragments or due to thermal damage of sensory nerves inside the vertebral body. Furthermore, the energy release during cement polymerization may cause thermal injury to the spinal cord or intervertebral discs. METHODS: A total of 4.0 mL PMMA was injected into three lumbar vertebrae of four skeletally mature mixed-bred ewes. Nine separate K-type thermocouples were placed into 12 vertebrae and their adjacent intervertebral discs. Temperature changes were recorded continuously before, during, and after the injection. RESULTS: The highest peak temperatures were measured at the cranial endplate (mean 42.4 +/- 8.8 C) and in the center of the vertebral body (mean 43.3 +/- 6.9 C). Temperatures stayed above 40 C for approximately 2.5 minutes. Peak temperatures in the discs and at the dorsal wall (closest to spinal cord) did not exceed 41 C and 47 C and stayed above 40 C for approximately 1.5 minutes. CONCLUSIONS: The intervertebral discs and the spinal cord do not seem to be in danger of thermal damage during vertebroplasty. The measured energy does not seem to be sufficient for the palliative effect achieved by vertebroplasty.

Racing prognosis of horses following surgically repaired olecranon fractures.

Olecranon fracture is a common orthopedic problem in juvenile horses. Prognosis for complete fracture healing when various methods of internal fixation are used is good; however, the impact of olecranon fracture stabilization on the likelihood that foals will start on a racecourse is unknown. Medical records of foals undergoing internal fixation for an olecranon fracture were reviewed. The dam's foaling records were obtained and lifetime racing records were then retrieved for both the affected foals and 1 of their siblings. Twenty-two of 24 repaired fractures healed completely, subsequently, 16 of the foals started in at least 1 race. Statistical calculations suggest that when compared with their siblings, the occurrence of olecranon factures requiring internal fixation in juvenile racehorses will not significantly reduce the likelihood that they will race; however, the siblings had significantly more lifetime race starts and higher career earnings.

A lag-screw technique for bridging of the medial aspect of the distal tibial physis in horses.

A lag-screw technique for transphyseal bridging of the medial aspect of the distal tibial physis in foals with tarsal valgus deformities and results of the technique in 11 foals (6 with bilateral tarsal valgus deformities and 5 with unilateral tarsal valgus deformities) are described. Briefly, horses were anesthetized, and a single stab incision was made through the skin to the underlying bone over the most distal aspect of the medial malleolus. A 20-gauge needle was placed in the incision to guide screw placement, and a lag screw was inserted parallel to the medial cortex of the tibia under radiographic guidance. Screws were removed when the tarsal valgus deformity was clinically assessed to have improved by at least 80%. Clinically, all horses had evidence of a tarsal valgus deformity of > 7 degrees prior to surgery. Mean age at the time of lag-screw implanation was 220 days (range, 116 to 364 days). Mean time the implant was in place was 62 days (range, 39 to 89 days). The tarsal valgus deformity resolved in all 11 horses with excellent cosmetic results.