Effectiveness of Orthotic Treatment on Clinical Outcomes of the Patients with Adolescent Idiopathic Scoliosis Under Different Wearing Compliance Levels: A Systematic Review.

BACKGROUND: Wearing spinal orthosis for 16 to 23 hours a day during the teenage years could be challenging and stressful for patients with adolescent idiopathic scoliosis (AIS). The investigation of clinical outcomes under various orthosis-wearing compliances can provide helpful insight into orthotic treatment dosage. This systematic review aims to investigate actual orthosis-wearing compliance and evaluate the effectiveness of orthotic treatment in controlling scoliotic curvature and preventing surgery for patients with AIS under various levels of orthosis-wearing compliance. METHODS: A literature search of 7 electronic databases, namely PubMed, MEDLINE, Cochrane Library, Scopus, CINAHL Complete, Web of Science, and Embase, was conducted on May 19, 2023. Participant characteristics, orthotic treatment protocols, compliance information, outcome measures, and key findings were extracted. The Newcastle-Ottawa Scales were used to evaluate the quality of included cohort and case-control studies. RESULTS: This study systematically reviewed 17 of 1,799 identified studies, including 1,981 subjects. The actual compliance was inconsistent and ranged from 7.0 to 18.8 hours daily. The proportion of compliant subjects in each study varied from 16.0% to 78.6% due to the heterogeneity of calculation period, measurement methods, and orthosis prescription time. Thirteen studies were investigated to determine the effectiveness of orthotic treatment in controlling curve deformity under different compliance groups, and 2 studies compared the compliance under different treatment outcomes. The rate of curve progression, defined as surpassing the measurement error threshold of 5° or 6° after orthotic treatment, varied from 1.8% to 91.7% across the studies. Ten studies defined the treatment failure, surgery, or surgery indication as Cobb angle progressing to a certain degree (e.g., 40°, 45°, or 50°) and reported failure/surgery/surgery indication rates ranging from 0.0% to 91.7% among different compliance level groups. CONCLUSION: This review found that the actual compliance with orthotic treatment was generally lower than the prescribed wearing time and exhibited wide variation among different studies. The electronic compliance monitors show promise in regular orthotic treatment practice. More importantly, the group with higher and consistent compliance has significantly less curve progression and lower surgery or failure rate than the group with lower and inconsistent compliance. Further studies are proposed to investigate the minimal orthosis-wearing compliance in patients with AIS treated with different types of orthoses. LEVEL OF EVIDENCE: Level III, Systematic Review. See Instructions for Authors for a complete description of levels of evidence.

Quality of life among adolescents with idiopathic scoliosis in Tunisia.

Introduction: our study aimed to assess the quality of life (QOL) among adolescents with adolescent idiopathic scoliosis (AIS) receiving nonoperative treatment, and to identify the demographic and clinical factors associated with poor QOL. Methods: this is a cross-sectional study. We included adolescents followed in the Department of Physical Medicine and Rehabilitation at Taher Sfar Hospital (Mahdia - Tunisia). The Quality-of-Life Profile for Spine Deformities (QLPSD), the Scoliosis Research Society 22 questionnaire (SRS-22) and the visual analogue scale objectifying the QOL (EVA QOL) were used. Correlations between the QOL domains and selected characteristics were performed. Results: a total of 48 adolescents with AIS were included, with a mean age of 14.2 ± 2.1 years and a sex ratio (M/F) of 0.77. Adolescents who underwent rehabilitation treatment only had significantly better quality of life (QOL) scores than those with braces, as measured by three scales. Among brace wearers, we found a correlation between QOL and the degree of correction achieved by the brace, as measured by the EVA-QOL. We observed significant relationships between psychosocial status and age, correction angle, and treatment duration among braced patients, as measured by the QLPSD. Additionally, we found that dorsal flexibility was correlated with the correction angle and the treatment duration. According to the SRS-22, the overall QOL score of braced adolescents was significantly correlated with the correction obtained by the brace. Conclusion: wearing a brace in adolescent with AIS leads to a significant decrease in QOL according to the three QOL assessment scales.

Sports participation reduces the progression of idiopathic scoliosis and the need for bracing. An observational study of 511 adolescents with Risser 0-2 maturation stage.

BACKGROUND: In clinics and the literature, there are doubts about the indications and contraindications of sports to support rehabilitation treatment for adolescents with idiopathic scoliosis (IS). AIM: The aim of the study is to assess sports activities' effect and frequency in a large population of adolescents with idiopathic scoliosis (IS). DESIGN: Retrospective observational cohort study. SETTING: Tertiary referral institute specialized in the conservative treatment of scoliosis. POPULATION: consecutive patients in a clinical database of age ≥10, with juvenile or adolescent IS diagnosis, 11-25° Cobb curve, Risser Bone Maturity Score 0-2, no brace prescription, radiographic follow-up radiographs at 12±3 months. METHODS: At 12-month follow-up, radiograph, we considered progression an increase of scoliosis curve ≥5° Cobb and failure an increase to ≥25° Cobb - need of a brace. We calculated the Relative risk (RR) to compare the outcome of participants performing sports (SPORTS) or not (NO-SPORTS). We run a logistic regression with covariate adjustment to assess the effect of sports participation frequency on the outcome. RESULTS: We included 511 patients (mean age 11.9±1.2, 415 females). Participants in the NO-SPORTS group showed a higher risk of progression (RR=1.57, 95% CI: 1.16-2.12, P=0.004) and failure (RR=1.85, 95% CI: 1.19-2.86, P=0.007) than participants in SPORTS. Logistic regression confirmed that the more frequent the sports activities, the less probable progression (P=0.0004) and failure (P=0.004) were. CONCLUSIONS: This study shows that sports activities have a protective role against progression at 12-month follow-up in adolescents with milder forms of IS. Excluding high-level sports activities, the risks of progression and failure decrease with the increase in sports frequency per week. CLINICAL REHABILITATION IMPACT: Albeit non-specific, sports can help in the rehabilitation of patients with idiopathic scoliosis and reduce brace prescription.

Soft collar for acute cervical spine injury immobilisation -patient experiences and outcomes: A single centre mixed methods study.

BACKGROUND: Cervical collars are used as standard care for neck immobilisation after cervical spine injury. Although evidence for the most effective type of collar is lacking, there is evidence regarding adverse patient outcomes when managed in a semi or rigid collar. In response to the evidence of complications and adverse effects when using a hard collar, a large Australian adult trauma hospital that specializes in spinal care, changed its policy from hard to soft collars when managing acute cervical spine injury. OBJECTIVE: The aim of this study was to investigate patients' experiences and outcomes when wearing a soft collar for acute cervical spine injury management in hospital. METHOD: A single centre mixed method sequential study design was used. RESULTS: Medical records from 136 patients were examined and no adverse events resulting from collar use were recorded. Interviews with 20 patients revealed that they understood the value of wearing a soft collar. The soft collars were considered supportive and well tolerated, with good adherence to recommendations for use. CONCLUSIONS: Understanding the patients' experiences informs better care management. This study suggests that soft collars are well tolerated, do not result in pressure injuries or other adverse events and are suitable for managing acute cervical spine injury.

A systematic review on management and outcome of irreducible knee dislocations.

BACKGROUND: Irreducible knee dislocations (IKD) are rare and can often be missed or misdiagnosed. The incidence of knee dislocation is quoted between 0.01% and 0.2% of all orthopaedic injuries, with up to 4% of these dislocations sub-classified as irreducible. The primary aim of this systematic review was to analyse cases of IKD described in the literature, with a secondary aim of producing a streamlined approach for managing these patients. PATIENTS AND METHODS: A systematic review of the literature was conducted on 1st September 2021 in accordance with the PRISMA guidelines using the online databases Medline and EMBASE. The review was registered prospectively in the PROSPERO database. Case reports or clinical studies or reporting on IKD were included. The studies were appraised using the Methodological Index for Non-Randomized Studies (MINORS) tool and Newcastle-Ottawa quality assessment scale. RESULTS: The search strategy identified 60 studies eligible for inclusion, giving a total of 114 cases of IKD. Posterolateral dislocation was most common, seen in 85% of cases. The dimple sign was present in 70%. All cases required surgical intervention to achieve joint reduction. The most commonly involved structure blocking reduction was the medial collateral ligament (MCL)±medial structures, seen in 52.4%. MCL reconstruction or repair was carried out in 32.3% cases. The overall incidence of neurovascular injury was 9% and the overall complication rate was 14.4%. CONCLUSION: Based on the findings of this SR we conclude that: the most common type of IKDs are PL dislocations, and the MCL, medial retinaculum and capsule and vastus medialis oblique form the most common structures involved in block to reduction and often will require open reduction and repair in acute setting if arthroscopic reduction fails. The most common pattern of injury to ligament is likely to be ACL, PCL, MCL±other structures but the MCL will be the most commonly repaired ligament. The dimple sign is often present and is highly pathognomonic of IKD. The incidence of neurovascular injury is uncommon. The most common post-operative complications likely to be encountered is medial skin necrosis and postoperative knee stiffness. Therefore, patients should be mobilised as early as possible with ROM in hinge brace. LEVEL OF EVIDENCE: IV.

Effects of bracing on pelvic parameters in adolescent idiopathic scoliosis: A retrospective study.

To evaluate the effects of Chêneau bracing on Cobb's angle (CA) and spinopelvic parameters in adolescent idiopathic scoliosis (AIS) patients. In this retrospective study, we evaluated 51 AIS patients who received Chêneau bracing treatment between January 2020 and August 2021. The prebracing and in-bracing radiographs were analyzed about the spinopelvic parameters. The CA, pelvic coronal obliquity angle, thoracolumbar kyphosis (TLK), lumbar lordosis (LL), pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS), sagittal vertical angle, and coronal vertical angle were measured. Paired t-test was used to compare prebracing and in-bracing spinopelvic parameters. The Pearson correlation analysis was used to identify the relationships between the variations in the spinopelvic parameters. The mean age at the initiation of bracing was 13.6 ± 1.5 years. The mean prebracing CA was 24.0° ± 6.3°. There were no statistically significant differences between prebracing and in-bracing measurements of sagittal and coronal vertical angles. However, there were statistically significant differences between the prebracing and in-bracing measurements of the CA, pelvic coronal obliquity angle, TLK, LL, PT, and SS. A significant correlation was observed between PT and thoracolumbar kyphosis variations in the sagittal plane. The pelvic coronal obliquity angle variation was correlated to the prebracing pelvic coronal obliquity angle in the coronal plane. Chêneau's bracing effects of AIS can be extended to the pelvis. Affected by the Chêneau brace, the pelvis should be retro-rotated correspondingly to TLK hyperkyphosis on the sagittal plane, whereas in the coronal plane, pelvic obliquity was improved independently. The effect of Chêneau braces on the pelvic parameters should be fully considered before bracing treatment.

[The isolated posterior malleolus fracture].

This is a case report of a 26-year-old healthy female who sustained an isolated posterior malleolar fracture; diagnosed by X-ray, confirmed by CT and treated with an orthosis and full weightbearing. Subsequent weightbearing X-rays showed no displacement or concomitant injury. However rare, isolated posterior malleolar fracture may indicate a complex ankle injury and therefore warrant extra attention when diagnosed. The diagnosis is difficult due to diffuse symptoms and limited visualization on plain X-rays. Missed diagnoses might lead to persistent pain and arthrosis.

Prospective clinical results of an additive ligament bracing for stabilizing simple and complex elbow instabilities.

INTRODUCTION: Ligament bracing augments ligament repair using a non-absorbable suture tape. Although biomechanically an increase in primary stability has been proven, there is a lack of clinical evidence. Purpose of this study was to evaluate clinical results of patients treated with ligament bracing due to primary elbow instability, including an analysis of complications. Furthermore, clinical results for patients treated with and without early functional mobilization were compared. MATERIALS AND METHODS: This prospective case-series evaluated clinical and functional results from patients treated with ligament bracing due to primary elbow instability. Clinical outcome measures were range of motion (ROM) as well as objective and subjective elbow scores [Mayo Elbow Performance Score (MEPS); Disabilities of Arm, Shoulder and Hand Score (DASH score)]. Stability was evaluated sonographically by humero-radial gapping under varus stress. RESULTS: This study involved 34 patients treated with ligament bracing. After a mean follow-up of 12.9 months ROM was 112° ± 29, MEPS 88 ± 13 points, DASH 91 ± 11 points, and 84% were satisfied with their result. Lateral joint gapping was 2.4 mm. No significant difference was observed regarding a postoperative mobilization with and without limitations. Most common complication after ligament bracing was elbow stiffness including heterotopic ossifications in four patients (12%). CONCLUSION: Operatively treated elbow instability with additional ligament bracing results in good clinical outcomes with high patient satisfaction and recovery of elbow stability. The high primary stability of the ligament bracing allows early functional mobilization without bracing, which facilitates postoperative rehabilitation. Elbow stiffness with heterotopic ossification seems to be a potential complication. Furthermore, the optimal tensioning of the ligament bracing remains challenging, including the risk of an over tensioning. LEVEL OF EVIDENCE: III.

Venous Thromboembolism in Patients Discharged From the Emergency Department With Ankle Fractures: A Population-Based Cohort Study.

STUDY OBJECTIVE: Temporary lower limb immobilization may be a risk for venous thromboembolism. The purpose of this study was to examine the 90-day incidence of venous thromboembolism among patients discharged from an emergency department (ED) with ankle fractures requiring temporary immobilization. Secondary objectives were to examine individual factors associated with venous thromboembolism in this population and to compare the risk of venous thromboembolism in patients with ankle fractures against a priori-selected control groups. METHODS: This was a retrospective cohort study using province-wide health datasets from Ontario, Canada. We included patients aged 16 years and older discharged from an ED between 2013 and 2018 with closed ankle fractures requiring temporary immobilization. We estimated 90-day incidence of venous thromboembolism after ankle fracture. A Cox proportional hazards model was used to evaluate risk factors associated with venous thromboembolism, censoring at 90 days or death. Patients with ankle fractures were then propensity score matched to 2 control groups: patients discharged with injuries not requiring lower limb immobilization (ie, finger wounds and wrist fractures) to compare relative hazard of venous thromboembolism. RESULTS: There were 86,081 eligible patients with ankle fractures. Incidence of venous thromboembolism within 90 days was 1.3%. Factors associated with venous thromboembolism were older age (hazard ratio [HR]: 1.18; 95% confidence interval [CI]: 1.00 to 1.39), venous thromboembolism or superficial venous thrombosis history (HR: 5.18; 95% CI: 4.33 to 6.20), recent hospital admission (HR: 1.33; 95% CI: 1.05 to 1.68), recent nonankle fracture surgery (HR: 1.58; 95% CI: 1.30 to 1.93), and subsequent surgery for ankle fracture (HR: 1.80; 95% CI: 1.48 to 2.20). In the matched cohort, patients with ankle fractures had an increased hazard of venous thromboembolism compared to matched controls with finger wounds (HR: 6.31; 95% CI: 5.30 to 7.52) and wrist fractures (HR: 5.68; 95% CI: 4.71 to 6.85). CONCLUSION: The 90-day incidence of venous thromboembolism among patients discharged from the ED with ankle fractures requiring immobilization was 1.3%. These patients had a 5.7- to 6.3-fold increased hazard compared to matched controls. Certain patients immobilized for ankle fractures are at higher risk of venous thromboembolism, and this should be recognized by emergency physicians.

Conservative treatment and outcome of upper cervical spine fractures in young children: A STROBE-compliant case series.

ABSTRACT: Cervical spine (C-spine) fractures in young children are very rare, and little information on treatment modalities and functional, radiographic, and patient-reported outcome exists. In this 2-center, retrospective case series, we assessed subjective and functional mid-term outcomes in children aged ≤5 years whose C-spine fractures were treated nonoperatively.Between 2000 and 2018, 6 children (median age at injury: 23.5 months; range: 16-31 months) with C1 or C2 injuries were treated with Minerva cast/brace or soft collar brace at 1 of the 2 study centers. Two patients suffered C1 fractures, and 4 patients had lysis of the odontoid synchondrosis. Overall, 3 children had sustained polytrauma. One child died due to the consequences of massive head injury.For the primary outcome parameter, we recorded subjective symptoms such as pain and functional restrictions due to the sequelae of C-spine injuries at follow-up.Based on medical records, we also assessed the causes of injury, diagnostic procedures, treatments and complications, and time to fracture consolidation.Median follow-up of the 5 surviving children was 51 months (range: 36-160 months). At the latest follow-up, 4 of 5 children did not complain of any pain. One child who sustained an open head injury in combination with a subluxation of the odontoid and undisplaced fracture of the massa lateralis reported occasional headache. All patients experienced complete fracture healing and normal range of motion of the cervical spine.Median duration of cast/brace treatment was 8.5 weeks. Fracture healing was confirmed by computed tomography in all patients.All C-spine injuries were managed with either Minerva cast/Halo brace or soft collar brace without complications.In our retrospective case series, nonoperative treatment of atlas fractures and dislocations or subluxations of the odontoid in young children using Minerva casts or prefabricated Halo braces resulted in good subjective and functional outcomes at mid-term. We observed no complications of conservative treatment of C1 and C2 injuries in young children.

Philadelphia versus Miami-J cervical collar's impact on pulmonary function.

PURPOSE: The purpose of this study was to compare the effect of two types of cervical collars (Philadelphia and Miami-J) on pulmonary function and ventilation in healthy volunteers through spirometry, peak flow meter, and capnograph. METHOD: Initially, subjects were randomized into two groups in which the sequence of collars' fixation was reversed. Afterward, we assessed the pulmonary parameters without a cervical collar in all participants. Each group underwent two additional test conditions, including measurements after wearing a Philadelphia and Miami-J cervical collar. In any case, we took the measurements half an hour after the collar fixation. RESULTS: The mean age of participants was 48.34 ± 1.35 years. Following either type of collars application, there was a statistically significant decrease in FEV1, FEV1/FVC, FEF25-75%, and PEF (p < .001). However, FVC was not significantly changed (p = .157). CONCLUSION: In summary, we noted a statistically significant expiratory flow obstruction after both the Philadelphia and Miami-J cervical collar. These changes were not clinically significant in healthy volunteers, albeit may have ramifications in patients with pre-existing respiratory compromise.

What factor induces stress in patients with AIS under brace treatment? Analysis of a specific factor using exploratory factor analysis.

BACKGROUND: Stress from brace treatment in patients with adolescent idiopathic scoliosis (AIS) can deteriorate their quality of life. A Japanese version of the Bad Sobernheim Stress Questionnaire-Brace (JBSSQ-brace) was developed to assess the stress from brace treatment for Japanese patients with AIS. However, the specific factors causing stress under brace treatment have remained unknown. METHOD: We enrolled 69 consecutive Japanese patients with AIS. Stress from brace treatment was assessed by JBSSQ-brace and Scoliosis Research Society-22 (SRS-22) instruments. The correlations of JBSSQ-brace with SRS-22 score, patient demographics and Cobb angle were analyzed by Spearman's rank correlation. Exploratory factor analysis was used to determine the psychological factor causing stress from brace treatment. RESULTS: JBSSQ-brace score was correlated with total score of SRS-22, self-image and mental health domain, but not age, degree of curvature, or other domains of the SRS-22. Factor analysis detected one underlying factor, which was more related to Questions 4 or 5 with the factor loadings of 0.8 than Questions 1 or 6 with loadings of 0.65. CONCLUSION: Stress from brace treatment was not associated with age, spinal curve severity, pain, or satisfaction of treatment. Exploratory factor analysis suggested "anxious feeling about how we are perceived by others" induces the stress from brace treatment in Japanese patients with AIS.

Pelvic rotation parameters related to in-brace correction in patients with idiopathic scoliosis.

BACKGROUND: To identify the pelvic parameters affecting in-brace correction (IBC) in patients with idiopathic scoliosis (IS). METHODS: Patients with IS receiving Chêneau brace treatment in our scoliosis center from January 2019 to November 2019 were retrospectively analyzed. Pelvic rotation parameters, including pelvic incidence (PI), sacral slope (SS), pelvic tilt (PT), L/R ratio, were collected. Other radiographic data, such as Risser sign, coronal and sagittal balance, curve location, kyphosis, lordosis of each patient were also recorded to analyze their correlations with IBC. Correlation analyses were performed to identify the classified variables influencing IBC. The principal component analysis was used to extract common factors of radiographic parameters to eliminate interaction effects. The linear regression equation was established using principal components, the variables influencing IBC were identified. RESULTS: A cohort of 44 patients with IS (36 girls and 8 boys) were included in the present study. The mean IBC was 49.87% (range, 3%-100%). IBC of lumbar IS was negatively correlated with apical rotate factor (ARF, B = -0.385), mainly consisted of pelvic coronal plane rotation (PCPR, 0.449), Cobb angle (CA, 0.575), apical vertebral rotation (AVR, 0.918), and pelvic rotate factor (PRF, B = -0.387), mainly consisted of PT (0.861), PI (0.728), PCPR (-0.570). The regression equation of lumbar IS had statistical significance (F = 6.500, P = 0.005, R2 = 0.317), whereas statistically significance was not found in the regression equation of thoracic IS (F = 2.913, P = 0.106). The remaining parameters were not related to IBC. CONCLUSIONS: For lumbar IS, ARF and PRF have negative effects on IBC, coronal and sagittal rotation of the pelvis is related to IBC.

Indentation marks, skin temperature and comfort of two cervical collars: A single-blinded randomized controlled trial in healthy volunteers.

BACKGROUND: Collar-related pressure ulcers (CRPU) are a problem in trauma patients with a suspicion of cervical cord injury patients. Indentation marks (IM), skin temperature (Tsk) and comfort could play a role in the development of CRPU. Two comparable cervical collars are the Stifneck® and Philadelphia®. However, the differences between them remain unclear. AIM: To determine and compare occurrence and severity of IM, Tsk and comfort of the Stifneck® and Philadelphia® in immobilized healthy adults. METHODS: This single-blinded randomized controlled trial compared two groups of immobilized participants in supine position for 20 min. RESULTS: All participants (n = 60) generated IM in at least one location in the observed area. Total occurrence was higher in the Stifneck®-group (n = 95 versus n = 69; p = .002). Tsk increased significantly with 1.0  °C in the Stifneck®-group and 1.3 °C in the Philadelphia®-group (p = .024). Comfort was rated 3 on a scale of 5 (p = .506). CONCLUSION: The occurrence of IM in both groups was high. In comparison to the Stifneck®, fewer and less severe IM were observed from the Philadelphia®. The Tsk increased significantly with both collars; however, no clinical difference in increase of Tsk between them was found. The results emphasize the need for a better design of cervical collars regarding CRPU.

Brachial Plexus Palsy Because of Pavlik Harness Use: A Case Report.

CASE: A 2.5-month-old girl with bilateral hip dysplasia presented for orthopaedic evaluation and began treatment with a Pavlik harness. One month after the initiation of treatment, decreased use of the left upper extremity was noted, which was consistent with a brachial plexus palsy. The Pavlik harness was discontinued, and upper extremity function fully recovered within 8 weeks. CONCLUSIONS: The Pavlik harness is an effective treatment for hip dysplasia with a low-risk profile. This case serves to remind clinicians of the risk for upper extremity traction injury when a Pavlik harness is used in patients who are large for their chronological age.

Does bracing for adolescent idiopathic scoliosis affect operative results?

STUDY DESIGN: Retrospective comparative study. OBJECTIVES: We hypothesize that preoperative bracing for idiopathic scoliosis results in increased stiffness, as measured by reduced correction on bending films, ultimately leading to decreased surgical correction. Bracing is the primary nonoperative treatment for immature AIS patients with mild to moderate curves. For patients who fail bracing and proceed to operative intervention, it is unknown whether their nonoperative treatment impacts their surgical results. METHODS: We conducted a single-center, retrospective, comparative study on 181 consecutive adolescent idiopathic scoliosis patients, aged 11-17 years, who underwent posterior spine fusion between 2011 and 2013. Patient flexibility was measured as percent change in the curve angle of the spine from standing to supine bend. Overall curve correction was calculated as the preoperative to postoperative change in standing coronal measure divided by the preoperative measurement and reported as a percentage. RESULTS: One hundred and twelve subjects (62%) underwent bracing prior to fusion. Braced patients had similar preoperative major Cobb angles than unbraced patients (56.5 vs 59.0, p = 0.07). Preoperatively, braced patients achieved less primary curve correction in bending films (33.6%) than unbraced patients (40.6%, p = 0.003). Postoperatively, Cobb angle correction was not different between the braced (75.7%) and unbraced group (77.2%) overall (p = 0.41). There was no difference in blood loss (p = 0.14) or surgical time (p = 0.96) between braced and unbraced groups when adjusted for surgeon and number of levels fused. CONCLUSIONS: While braced patients may demonstrate less preoperative flexibility, there is no evidence that braced patients experience decreased curve correction compared to unbraced patients. Bracing treatment did not impact operative results, as indicated by similar Cobb angle correction, estimated blood loss, and surgical time in both groups. LEVEL OF EVIDENCE: III.

Plaster cast versus functional brace for non-surgical treatment of Achilles tendon rupture (UKSTAR): a multicentre randomised controlled trial and economic evaluation.

BACKGROUND: Patients with Achilles tendon rupture who have non-operative treatment have traditionally been treated with immobilisation of the tendon in plaster casts for several weeks. Functional bracing is an alternative non-operative treatment that allows earlier mobilisation, but evidence on its effectiveness and safety is scarce. The aim of the UKSTAR trial was to compare functional and quality-of-life outcomes and resource use in patients treated non-operatively with plaster cast versus functional brace. METHODS: UKSTAR was a pragmatic, superiority, multicentre, randomised controlled trial done at 39 hospitals in the UK. Patients (aged ≥16 years) who were being treated non-operatively for a primary Achilles tendon rupture at the participating centres were potentially eligible. The exclusion criteria were presenting more than 14 days after injury, previous rupture of the same Achilles tendon, or being unable to complete the questionnaires. Eligible participants were randomly assigned (1:1) to receive a plaster cast or functional brace using a centralised web-based system. Because the interventions were clearly visible, neither patients nor clinicians could be masked. Participants wore the intervention for 8 weeks. The primary outcome was patient-reported Achilles tendon rupture score (ATRS) at 9 months, analysed in the modified intention-to-treat population (all patients in the groups to which they were allocated, excluding participants who withdrew or died before providing any outcome data). The main safety outcome was the incidence of tendon re-rupture. Resource use was recorded from a health and personal social care perspective. The trial is registered with ISRCTN, ISRCTN62639639. FINDINGS: Between Aug 15, 2016, and May 31, 2018, 1451 patients were screened, of whom 540 participants (mean age 48·7 years, 79% male) were randomly allocated to receive plaster cast (n=266) or functional brace (n=274). 527 (98%) of 540 were included in the modified intention-to-treat population, and 13 (2%) were excluded because they withdrew or died before providing any outcome data. There was no difference in ATRS at 9 months post injury (cast group n=244, mean ATRS 74∙4 [SD 19∙8]; functional brace group n=259, ATRS 72∙8 [20∙4]; adjusted mean difference -1∙38 [95% CI -4∙9 to 2∙1], p=0·44). There was no difference in the rate of re-rupture of the tendon (17 [6%] of 266 in the plaster cast group vs 13 [5%] of 274 in the functional brace group, p=0·40). The mean total health and personal social care cost was £1181 for the plaster cast group and £1078 for the functional bract group (mean between-group difference -£103 [95% CI -289 to 84]). INTERPRETATION: Traditional plaster casting was not found to be superior to early weight-bearing in a functional brace, as measured by ATRS, in the management of patients treated non-surgically for Achilles tendon rupture. Clinicians may consider the use of early weight-bearing in a functional brace as a safe and cost-effective alternative to plaster casting. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.

Bayesian adaptive designs for multi-arm trials: an orthopaedic case study.

BACKGROUND: Bayesian adaptive designs can be more efficient than traditional methods for multi-arm randomised controlled trials. The aim of this work was to demonstrate how Bayesian adaptive designs can be constructed for multi-arm phase III clinical trials and assess potential benefits that these designs offer. METHODS: We constructed several alternative Bayesian adaptive designs for the Collaborative Ankle Support Trial (CAST), which was a randomised controlled trial that compared four treatments for severe ankle sprain. These designs incorporated response adaptive randomisation (RAR), arm dropping, and early stopping for efficacy or futility. We studied the operating characteristics of the Bayesian designs via simulation. We then virtually re-executed the trial by implementing the Bayesian adaptive designs using patient data sampled from the CAST study to demonstrate the practical applicability of the designs. RESULTS: We constructed five Bayesian adaptive designs, each of which had high power and recruited fewer patients on average than the original designs target sample size. The virtual executions showed that most of the Bayesian designs would have led to trials that declared superiority of one of the interventions over the control. Bayesian adaptive designs with RAR or arm dropping were more likely to allocate patients to better performing arms at each interim analysis. Similar estimates and conclusions were obtained from the Bayesian adaptive designs as from the original trial. CONCLUSIONS: Using CAST as an example, this case study shows how Bayesian adaptive designs can be constructed for phase III multi-arm trials using clinically relevant decision criteria. These designs demonstrated that they can potentially generate earlier results and allocate more patients to better performing arms. We recommend the wider use of Bayesian adaptive approaches in phase III clinical trials. TRIAL REGISTRATION: CAST study registration ISRCTN, ISRCTN37807450. Retrospectively registered on 25 April 2003.