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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., (Copyright © 2020 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Purpose: To determine consensus among Asia-Pacific surgeons regarding nonoperative management for adolescent idiopathic scoliosis (AIS)., Methods: An online REDCap questionnaire was circulated to surgeons in the Asia-Pacific region during the period of July 2019 to September 2019 to inquire about various components of nonoperative treatment for AIS. Aspects under study included access to screening, when MRIs were obtained, quality-of-life assessments used, role of scoliosis-specific exercises, bracing criteria, type of brace used, maturity parameters used, brace wear regimen, follow-up criteria, and how braces were weaned. Comparisons were made between middle-high income and low-income countries, and experience with nonoperative treatment., Results: A total of 103 responses were collected. About half (52.4%) of the responders had scoliosis screening programs and were particularly situated in middle-high income countries. Up to 34% obtained MRIs for all cases, while most would obtain MRIs for neurological problems. The brace criteria were highly variable and was usually based on menarche status (74.7%), age (59%), and Risser staging (92.8%). Up to 52.4% of surgeons elected to brace patients with large curves before offering surgery. Only 28% of responders utilized CAD-CAM techniques for brace fabrication and most (76.8%) still utilized negative molds. There were no standardized criteria for brace weaning., Conclusion: There are highly variable practices related to nonoperative treatment for AIS and may be related to availability of resources in certain countries. Relative consensus was achieved for when MRI should be obtained and an acceptable brace compliance should be more than 16 hours a day.

Background: Multiple randomized trials have showed equivalent outcomes and improved patient/family satisfaction using a removable brace to treat pediatric distal radius buckle fractures (DRBF). We tested the hypothesis that we could use quality improvement (QI) methodology to increase the proportion of patients with DRBF treated with removable braces at 2 tertiary care orthopaedic clinics from a baseline of 34.8% to 80%., Methods: Clinic billing records were reviewed monthly to determine treatment (brace vs. cast) of DRBF and tracked using control charts (p-chart). Balance measures including correct application of the diagnostic criteria and algorithm were monitored. Process measures including the number of follow-up visits, radiographs obtained, and total cost of treatment were collected. Baseline data were obtained over a 3-month period, followed by a 12-month period of interventions using Plan-Do-Study-Act cycles targeting both individuals and groups of providers., Results: The proportion of DRBF treated in a brace increased from a combined baseline of 34.8% to a combined 84% at the end of the study period. Following intervention, 83% (15/18) of providers began using braces for a majority of patients (defined as >67%), with only 1 provider continuing to use casts 100% of the time. Patient preference was cited as the most common reason for use of cast treatment. There was a significant decrease in the number of radiographs obtained at 1 of 2 institutions. The charges for brace treatment averaged $630 less per patient than for cast treatment, leading to an estimated medical-cost savings of $205,000 following intervention., Conclusions: Implementation of brace treatment for pediatric DRBF using QI methodology resulted in a shift toward brace treatment in the majority of patients, leading to substantial medical and nonmedical cost savings. Although patient preference was cited as the most common reason for persistent cast treatment, the data show the use of cast treatment to be more dependent upon individual provider preference., Level of Evidence: Level II-therapeutic.

Background Context: Bracing is often used after spinal surgery to immobilize the spine, improve fusion, and relieve pain. However, controversy exists regarding the efficacy, necessity, and safety of various bracing techniques in the postsurgical setting., Purpose: In this systematic review, we aimed to compare the effectiveness, safety, and cost-effectiveness of postoperative bracing versus no postoperative bracing after spinal surgery in patients with several common operative spinal pathologies., Study Design/setting: A systematic review was carried out to compare postoperative bracing and no postoperative bracing., Methods: A systematic search was conducted of MEDLINE, Embase, and the Cochrane Collaboration Library from 1970 to May 2017, supplemented by manual searching of the reference list of relevant studies and previously published reviews. Studies were included if they compared disability, quality of life, functional impairment, radiographic outcomes, cost-effectiveness, or complications between patients treated with postoperative bracing and patients not receiving any postoperative bracing. Each article was critically appraised independently by two reviewers, and the overall body of evidence was rated using guidelines outlined by the Grading of Recommendation Assessment, Development and Evaluation (GRADE) Working Group., Results: Of the 858 retrieved citations, 5 studies met the inclusion criteria and were included in this review, consisting of 4 randomized controlled trials and 1 prospective cohort study. Low to moderate evidence suggests that there are no significant differences in most measures of disability, pain, quality of life, functional impairment, radiographic outcomes, and safety between groups. Isolated studies reported statistically significant and inconsistent differences between groups with respect to Neck Disability Index at 6 weeks postoperatively or Short Form-36 Physical Component Score at 1.5, 3, 6, and 12 months postoperatively., Conclusions: Based on limited evidence, postoperative bracing does not result in improved outcomes after spinal surgery. Future high-quality randomized trials will be required to confirm these findings., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Around 100,000 children are born annually with clubfoot worldwide and 80% live in low and middle-income counties (LMICs). Clubfoot is a condition in which children are born with one or both feet twisted inwards and if untreated it can limit participation in everyday life. Clubfoot can be corrected through staged manipulation of the limbs using the Ponseti method. Despite its efficacy and apparent availability, previous research has identified a number of challenges to service implementation. The aim of this study was to synthesise these findings to explore factors that impact on the implementation of clubfoot services in LMICs and strategies to address them. Understanding these may help practitioners in other settings develop more effective services., Methods: Five databases were searched and articles screened using six criteria. Articles were appraised using the Critical Appraisal Skills Programme (CASP) checklist. 11 studies were identified for inclusion. A thematic analysis was conducted., Results: Thematic analysis of the included studies showed that a lack of access to resources was a challenge including a lack of casting materials and abduction braces. Difficulties within the working environment included limited space and a need to share treatment space with other clinics. A shortage of healthcare professionals was a concern and participants thought that there was a lack of time to deliver treatment. This was exacerbated by the competing demands on clinicians. Lack of training was seen to impact on standards, including the nurses and midwives attending to the child at birth that were failing to diagnose the condition. Financial constraints were seen to underlie many of these problems. Some participants identified failures in communication and cooperation within the healthcare system such as a lack of awareness of clinics. Strategies to address these issues included means of increasing resource availability and the delivery of targeted training. The use of non-governmental organisations to provide financial support and methods to disseminate best practice were discussed., Conclusions: This study identified factors that impact on the implementation of clubfoot services in LMIC settings.Findings may be used to improve service delivery.

Background: Recent guidelines from the Eastern Association for the Surgery of Trauma conditionally recommend cervical collar removal after a negative cervical computed tomography in obtunded adult blunt trauma patients. Although the rates of missed injury are extremely low, the impact of chronic care costs and litigation upon decision making remains unclear. We hypothesize that the cost-effectiveness of strategies that include additional imaging may contradict current guidelines., Methods: A cost-effectiveness analysis was performed for a base-case 40-year-old, obtunded man with a negative computed tomography. Strategies compared included adjunct imaging with cervical magnetic resonance imaging (MRI), collar maintenance for 6 weeks, or removal. Data on the probability for long-term collar complications, spine injury, imaging costs, complications associated with MRI, acute and chronic care, and litigation were obtained from published and Medicare data. Outcomes were expressed as 2014 US dollars and quality-adjusted life-years., Results: Collar removal was more effective and less costly than collar use or MRI (19.99 vs. 19.35 vs. 18.70 quality-adjusted life-years; $675,359 vs. $685,546 vs. $685,848) in the base-case analysis. When the probability of missed cervical injury was greater than 0.04 adjunct imaging with MRI dominated, however, collar removal remained cost-effective until the probability of missed injury exceeded 0.113 at which point collar removal exceeded the $50,000 threshold. Collar removal remained the most cost-effective approach until the probability of complications from collar use was reduced to less than 0.009, at which point collar maintenance became the most cost-effective strategy. Early collar removal dominates all strategies until the risk of complications from MRI positioning is reduced to 0.03 and remained cost-effective even when the probability of complication was reduced to 0., Conclusion: Early collar removal in obtunded adult blunt trauma patients appears to be the most effective and least costly strategy for cervical clearance based on the current literature available., Level of Evidence: Economic evaluation, level III; therapeutic study, level IV.

Aims and Objectives: To examine the cost-effectiveness of semi-rigid ankle brace to facilitate return to work following first-time acute ankle sprains., Design: Economic evaluation based on cost-utility analysis., Background: Ankle sprains are a source of morbidity and absenteeism from work, accounting for 15-20% of all sports injuries. Semi-rigid ankle brace and taping are functional treatment interventions used by Musculoskeletal Physiotherapists and Nurses to facilitate return to work following acute ankle sprains., Methods: A decision model analysis, based on cost-utility analysis from the perspective of National Health Service was used. The primary outcomes measure was incremental cost-effectiveness ratio, based on quality-adjusted life years. Costs and quality of life data were derived from published literature, while model clinical probabilities were sourced from Musculoskeletal Physiotherapists., Results: The cost and quality adjusted life years gained using semi-rigid ankle brace was £184 and 0.72 respectively. However, the cost and quality adjusted life years gained following taping was £155 and 0.61 respectively. The incremental cost-effectiveness ratio for the semi-rigid brace was £263 per quality adjusted life year. Probabilistic sensitivity analysis showed that ankle brace provided the highest net-benefit, hence the preferred option., Conclusion: Taping is a cheaper intervention compared with ankle brace to facilitate return to work following first-time ankle sprains. However, the incremental cost-effectiveness ratio observed for ankle brace was less than the National Institute for Health and Care Excellence threshold and the intervention had a higher net-benefit, suggesting that it is a cost-effective intervention. Decision-makers may be willing to pay £263 for an additional gain in quality adjusted life year., Relevance to Clinical Practice: The findings of this economic evaluation provide justification for the use of semi-rigid ankle brace by Musculoskeletal Physiotherapists and Nurses to facilitate return to work in individuals with first-time ankle sprains., (© 2016 John Wiley & Sons Ltd.)

Background: The aim of our study is to evaluate the ability of a pre- fabricated humeral bracing system in providing sufficient stability to fracture union and carry out a cost analysis comparing bracing versus surgical fixation for these fractures., Material and Methods: A review of humeral shaft fractures treated with a pre-fabricated humeral bracing system was undertaken., Results: 20 humeral fractures (20 patients) were included. Mean patient age was 56.8 years (range 16- 89). There were 14 AO type A, 3 type B and 3 type C fractures. Median time interval from fracture to brace application was 8 days (range 0-41). Clinical and radiological union was achieved in 15 humeri (75%). Median time to clinical and radiological union was 80 days (range 32-434). The cost of treating humeral shaft fractures surgically by plating and by humeral bracing was estimated at £ 2292.99 and £ 1228 per case, respectively., Conclusions: 1. A pre-fabricated bracing system is an efficacious and cost-effective modality for humeral shaft fracture treatment. 2. It may, however, lead to a high non-union rate as well as shoulder and elbow stiffness. 3. A prospective randomized trial comparing bracing with internal fixation of humeral shaft fractures is needed.

Traumatic dislocations of the shoulder commonly present to emergency departments (EDs). Immediate closed reduction of both anterior and posterior glenohumeral dislocations is recommended and is frequently performed in the ED. Recurrence of dislocation is common, as anteroinferior labral tears (Bankart lesions) are present in many anterior shoulder dislocations.14,15,18,23 Immobilization of the shoulder following closed reduction is therefore recommended; previous studies support the use of immobilization with the shoulder in a position of external rotation, for both anterior and posterior shoulder dislocations.7-11,19 In this study, we present a technique for assembling a low-cost external rotation shoulder brace using materials found in most hospitals: cotton roll, stockinette, and shoulder immobilizers. This brace is particularly suited for the uninsured patient, who lacks the financial resources to pay for a pre-fabricated brace out of pocket. We also performed a cost analysis for our low-cost external rotation shoulder brace, and a cost comparison with pre-fabricated brand name braces. At our institution, the total materials cost for our brace was $19.15. The cost of a pre-fabricated shoulder brace at our institution is $150 with markup, which is reimbursed on average at $50.40 according to our hospital billing data. The low-cost external rotation shoulder brace is therefore a more affordable option for the uninsured patient presenting with acute shoulder dislocation.

Background: Clubfoot is disabling, with an incidence of 0.9/1,000 live births to 7/1,000 live births. It affects mobility, productivity, and quality of life. Patients are treated surgically or non-surgically using the Ponseti method. We estimated the cost per patient treated with both methods and the cost-effectiveness of these methods in Pakistan., Methods: Parents of patients treated, either surgically or with the Ponseti method, at the Indus Hospital's free program for clubfoot were interviewed between February and May 2012. We measured the direct and indirect household expenditures for pre-diagnosis, incomplete treatment, and current treatment until the first brace for Ponseti method and the first corrective surgery for surgically treated patients. Hospital expenditure was measured by existing accounts., Results: Average per-patient cost was $349 for the Ponseti method and $810 for patients treated surgically. Of these, the Indus hospital costs were $170 the for Ponseti method and $452 for surgically treated patients. The direct household expenditure was $154 and $314 for the Ponseti and surgical methods, respectively. The majority of the costs were incurred pre-diagnosis and after inadequate treatment, with the largest proportion spent on transportation, material, and fee for service. The Ponseti method is shown to be the dominant method of treatment, with an incremental cost-effectiveness ratio of $1,225., Conclusions: The Ponseti method is clearly the treatment of choice in resource-constrained settings like Pakistan. Household costs for clubfoot treatment are substantial, even in programs offering free diagnostics and treatments and may be a barrier to service utilization for the poorest patients.

Objective: The results of two randomized clinical trials (RCTs) demonstrate the clinical effectiveness of alternatives to casting for certain ankle and wrist fractures. We illustrate the use of value of information (VOI) methods for evaluating the evidence provided by these studies with respect to decision making., Study Design and Setting: Using cost-effectiveness data from these studies, the expected value of sample information (EVSI) of a future RCT can be determined. If the EVSI exceeds the cost of the future trial for any sample size, then the current evidence is considered insufficient for decision making and a future trial is considered worthwhile. If, on the other hand, there is no sample size for which the EVSI exceeds the cost, then the evidence is considered sufficient, and no future trial is required., Results: We found that the evidence from the ankle study was insufficient to support the adoption of the removable device and determined the optimal sample size for a future trial. Conversely, the evidence from the wrist study was sufficient to support the adoption of the removable device., Conclusions: VOI methods provide a decision-analytic alternative to the standard hypothesis testing approach for assessing the evidence provided by cost-effectiveness studies and for determining sample sizes for RCTs., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: There is controversial evidence regarding whether foot orthoses or knee braces improve pain and function or correct malalignment in selected patients with osteoarthritis (OA) of the medial knee compartment. However, insoles are safe and less costly than knee bracing if they relieve pain or improve function., Questions/purposes: We therefore asked whether laterally wedged insoles or valgus braces would reduce pain, enhance functional scores, and correct varus malalignment comparable to knee braces., Patients and Methods: We prospectively enrolled 91 patients with symptomatic medial compartmental knee OA and randomized to treatment with either a 10-mm laterally wedged insole (index group, n = 45) or a valgus brace (control group, n = 46). All patients were assessed at 6 months. The primary outcome measure was pain severity as measured on a visual analog scale. Secondary outcome measures were knee function score using WOMAC and correction of varus alignment on AP whole-leg radiographs taken with the patient in the standing position. Additionally, we compared the percentage of responders according to the OMERACT-OARSI criteria for both groups., Results: We observed no differences in pain or WOMAC scores between the two groups. Neither device achieved correction of knee varus malalignment in the frontal plane. According to the OMERACT-OARSI criteria, 17% of our patients responded to the allocated intervention. Patients in the insole group complied better with their intervention. Although subgroup analysis results should be translated into practice cautiously, we observed a slightly higher percentage of responders for the insole compared with bracing for patients with mild medial OA., Conclusions: Our data suggest a laterally wedged insole may be an alternative to valgus bracing for noninvasively treating symptoms of medial knee OA., Level of Evidence: Level I, therapeutic study. See the Guidelines for Authors for a complete description of level of evidence.

In 2005, a nationwide clubfoot treatment program focused on the Ponseti method -an effective, affordable and minimally-invasive method- was initiated in China. The purpose of this study was to evaluate and identify barriers to the program. A qualitative study (rapid ethnographic study) was conducted using semi-structured interviews of 44 physicians who attended four of the 10 Ponseti training workshops, focus groups with parents of children with clubfoot, and observation. Several barriers to the Ponseti method are quite unique due to China's size, socio-economics, culture, politics, and healthcare systems. The barriers were classified into seven themes: (i) physician education, (ii) caregiver compliance, (iii) culture, (iv) public awareness, (v) poverty, (vi) financial constraints for physicians/hospitals, and (vii) challenges of the treatment process. A number of suggestions that could be helpful in reducing or eliminating the effects of these barriers were also identified: (i) pamphlets explaining clubfoot and treatment for caregivers, (ii) directories of Ponseti providers, (iii) funding/financial support, and (iv) improving public awareness. The information from this study provides healthcare planners with knowledge to assist in meeting the needs of the population and continued implementation of effective and culturally appropriate awareness and treatment programs for clubfoot throughout China.

Bracing is a critical component of the current standard of treatment for clubfoot. Adherence to the bracing protocol is the main factor for the long-term success of the treatment The purpose of this paper is to provide a review of clubfoot braces, best practices in brace design and recommendations for bracing in order to improve adherence with the bracing phase of the clubfoot treatment. There are a number of designs and offerings of braces available in various regions of the world. Although many new brace designs are being proposed and developed, evidence in the literature regarding biomechanical effects, clinical outcomes, functionality and patient adherence is limited. The current research that is available regarding brace design focuses on increasing patient comfort and satisfaction to improve adherence. Although the currently available braces are widely distributed in developed countries, access is limited to many parts of the world. When considering the future of the clubfoot treatment and prevention of relapses, since 80% of the cases are in developing countries with limited resources, brace cost and availability needs to be assessed.

Background: Congenital clubfoot treatment continues to be controversial particularly in a resource-constrained country. Comparative evaluation of clubfoot surgery with Ponseti methods has not been reported in West Africa., Objectives: To determine the effects of Ponseti techniques on clubfoot surgery frequency and patterns in Nigeria., Methods: This was a prospective hospital-based intention-to-treat comparative study of clubfoot managed with Ponseti methods (PCG) and extensive soft tissue surgery (NPCG). The first step was a nonselective double-blind randomization of clubfoot patients into two groups using Excel software in a university teaching hospital setting. The control group was the NPCG patients. The patients' parents gave informed consent, and the medical research and ethics board approved the study protocol. Biodata was gathered, clubfoot patterns were analyzed, Dimeglio-Bensahel scoring was done, the number of casts applied was tallied, and patterns of surgeries were documented. The cost of care, recurrence and outcomes were evaluated. Kruskal-Wallis analysis and Mann-Whitney U technique were used, and an alpha error of < 0.05 at a CI of 95% were taken to be significant., Results: We randomized 153 clubfeet (in 105 clubfoot patients) into two treatment groups. Fifty NPCG patients (36.2%) underwent manipulation and extensive soft tissue surgery and 55 PCG patients (39.9%) were treated with Ponseti methods. Fifty-two patients of the Ponseti group had no form of surgery (94.5% vs. 32%, p<0.000). Extensive soft tissue surgery was indicated in 17 (34.0%) of the NPCG group, representing 8.9% of the total of 191 major orthopaedic surgeries within the study period. Thirty-five patients (70.0%) from the NPCG group required more than six casts compared to thirteen patients (23.6%) of the PCG (p<0.000). The mean care cost was high within the NPCG when compared to the Ponseti group (48% vs. 14.5%, p<0.000). The Ponseti-treated group had fewer treatment complications (p<0.003), a lower recurrence rate (p<0.000) and satisfactory early outcome (p<0.000)., Conclusion: Major clubfoot surgery was not commonly indicated among patients treated with the Ponseti method. The Ponseti clubfoot technique has reduced total care costs, cast utilization, clubfoot surgery frequency and has also changed the patterns of surgery performed for clubfoot in Nigeria.

This study compared market prices (i.e. third-party reimbursement and patient co-payment) of prefabricated neck, wrist and knee braces in Belgium, France, the Netherlands, Ontario (Canada) and the UK. Data were collected through contacts with health authorities, health insurance funds, manufacturers and distributors. Market prices varied substantially between countries, indicating that manufacturers adapt their price setting strategy to the policy environment and the structure of the brace market of a country. Belgian prices tended to exceed prices in other countries for the selected neck, wrist and knee braces. There seems to be scope for reducing Belgian prices of selected braces.

Study Objective: Fractures in children may not be visible in the result of initial radiography, and undertreatment and overtreatment of such fractures routinely occur. The purpose of this study was to evaluate the potential cost of implementing limited magnetic resonance imaging (MRI) at initial encounter, when radiographs are unrevealing., Methods: This was a retrospective review of 204 emergency department pediatric patients presenting between January 1, 2005 and February 28, 2006 with appendicular trauma, with initially negative radiographic result and follow-up. Emergency department treatment categorization of (1) no treatment, (2) ACE wrap, (3) brace, (4) splint, or (5) casting was evaluated. Final determination of presence or absence of fracture was based on follow-up. Patients with fractures were considered undertreated when they received categories 1 to 3 care; patients without fractures were considered overtreated when they received categories 4 and 5 care. The percentage of patients undertreated or overtreated and direct and total costs were determined and analyzed in conjunction with the cost of a limited MRI at initial encounter. Total costs include direct and indirect costs (lost wages for each day off work for the parent). Cost estimates assume patients determined to be without fractures at follow-up will not return for follow-up clinical care or obtain additional imaging after MRI at initial encounter., Results: Twenty-eight (13.7%) of the 204 patients had fractures at follow-up. Fifty one percent of patients without fractures were overtreated; 29% with fractures were undertreated. Mean direct cost for all patients and cost estimation with limited MRI protocol were $843.81 and $891.79, respectively (P = 0.365). However, mean total cost for all patients and cost estimation with limited MRI protocol was $1059.49 and $929.10, respectively (P = 0.02)., Conclusions: Based on clinical grounds and initially negative radiographic results, slightly more than half of patients without fractures can be overtreated, and nearly one third of patients with fractures can be undertreated. Instituting a protocol that includes limited trauma MRI lowers the total cost of care without increasing direct cost, and appropriate care may be instituted at the outset.

Objective: To estimate the clinical effectiveness and cost-effectiveness of three methods of ankle support compared with double layer tubular compression bandage., Design: A randomised controlled trial, designed to reflect practice in UK hospital emergency departments., Setting: Eight emergency departments in England., Participants: Aged 16 or over with acute severe ankle sprain, unable to weight bear, no fracture., Interventions: 584 participants were randomised to one of four treatment arms: tubular bandage, below knee cast, Aircast ankle brace or Bledsoe boot, all applied 2-3 days after presentation to allow swelling to resolve., Main Outcome Measures: Response to treatment was assessed using the Foot and Ankle Outcome Score and generic measures (Functional Limitations Profile, SF-12 and EQ-5D)., Results: When adjusted for age, sex and baseline scores, the below knee cast offered a small but statistically significant benefit at 4 weeks in terms of pain (FAOS pain difference 5.1; 95% CI 0.4-9.8), foot- and ankle-related quality of life (QoL) (FAOS QoL difference 5.9; 95% CI 0.1-11.8) and the physical component of the SF-12 (SF-12 score difference 2.2; 95% CI 0.0-4.4). Neither the Aircast brace nor the Bledsoe boot was statistically or clinically better. At 12 weeks the below knee cast was significantly better than tubular bandage in terms of pain (FAOS pain difference 5.1; 95% CI 0.3-10.0), activities of daily living (FAOS ADL difference 3.5; 95% CI 0.4-6.6), sports (FAOS sports difference 8.7; 95% CI 1.6-15.7) and QoL (FAOS QoL difference 8.7; 95% CI 2.4-15.0), and the Aircast brace was better only in terms of ankle-related QoL and mental health. The Bledsoe boot conferred no significant advantage over tubular bandage. By 9 months there were no significant differences. Based on mean direct health-care costs per participant, the Bledsoe boot was the most expensive (215 pounds) and tubular bandage the least so (1 pound 44 pence). Inclusion of indirect costs (sick leave) raised overall costs substantially and removed any significant differences between the therapies. Cost-utility analysis demonstrated that the Aircast brace [301 pounds per quality-adjusted life-year (QALY)] and below knee cast (339 pounds per QALY) were more cost-effective than the Bledsoe boot (2116 pounds per QALY). However, inclusion of indirect costs produced different rank orders, depending on the assumptions made, and results should be treated with caution., Conclusions: The below knee cast and the Aircast brace offered cost-effective alternatives to tubular bandage for acute severe ankle sprain, the former having the advantage in terms of overall recovery at 3 months. As there were no differences in long-term outcome, practitioners should consider likely compliance and acceptability to patients when choosing a brace.

Study Design: Multicentric, randomized, and controlled study of clinical evaluation of medical device in subacute low back pain., Objective: To evaluate the effects of an elastic lumbar belt on functional capacity, pain intensity in low back pain treatment, and the benefice on medical cost., Summary of Background Data: There is limited evidence of efficiency of lumbar supports for treatment of low back pain. There is also a lack of the methodology in the studies reported on the efficiency of this device., Methods: This study is randomized, multicentric, and controlled with 2 groups: a patient group treated with a lumbar belt (BWG) and a control group (CG). The main criteria of clinical evaluation were the physical restoration assessed with the EIFEL scale, the pain assessed by a visual analogic scale, the main economical criteria was the overall cost of associated medical treatments., Results: One hundred ninety-seven patients have participated. The results show a higher decrease in EIFEL score in BWG than CG between days 0 and 90 (7.6 +/- 4.4 vs. de 6.1 +/- 4.7;P = 0.023). Respectively significant reduction in visual analogic scale was also noticed (41.5 +/- 21.4 vs. 32.0 +/- 20; P = 0.002). Pharmacologic consumption decreased at D90 (the proportion of patients who did not take any medication in BWG is 60.8% vs. 40% in CG;P = 0.029)., Conclusion: Lumbar belt wearing is consequent in subacute low back pain to improve significantly the functional status, the pain level, and the pharmacologic consumption. This study may be useful to underline the interest of lumbar support as a complementary and nonpharmacologic treatment beside the classic medication use in low back pain treatment.

Accurate and reproducible patient positioning is fundamental to the success of fractionated radiotherapy. Poor patient positioning could result in geographic misses. We have recently reported on an improved method of customized face mask production using laser surface scanning. In this report, we sought to identify and develop a method to routinely make customized neck supports for patients prescribed radiotherapy to the brain or head and neck regions. We identified a potentially suitable product--sealed packs containing two liquids that produce expanding polyurethane foam when mixed--and developed a method for their use. The neck supports are inexpensive and simple to produce (taking less than 5 min of radiation therapist labour). We assessed the customized neck supports in several ways. The effect on setup accuracy was assessed by comparing two consecutive cohorts of patients. Statistically significant differences favouring the customized neck supports included a reduced total displacement error (mean 3.4 vs. 2.1 mm) and a reduced left-right setup error (mean 1.8 vs. 1.1 mm). This is consistent with the greater support provided by the customized neck supports. This method could easily be undertaken by other departments.

We designed less expensive halo vest brace using an Ilizarov ring and a threaded rod, which is as effective as the normal halo vest. It can be used in any orthopedic set-up.

Objectives: Isolated distal fibular ankle fractures in children are very common and at very low risk for future complications. Nevertheless, standard therapy for these fractures still consists of casting, a practice that carries risks, inconveniences, and use of subspecialty health care resources. Therefore, the main objective of this study was to determine whether children who have these low-risk ankle fractures that are treated with a removable ankle brace have at least as effective a recovery of physical function as those that are treated with a cast., Methods: This was a noninferiority, randomized, single-blind trial in which children who were 5 to 18 years of age and treated in a pediatric emergency department for low-risk ankle fractures were randomly assigned to a removable ankle brace or a below-knee walking cast. The primary outcome at 4 weeks was physical function, measured by using the modified Activities Scale for Kids. Additional outcomes included patient preferences and costs., Results: The mean activity score at 4 weeks was 91.3% in the brace group (n = 54), and this was significantly higher than the mean of 85.3% in the cast group (n = 50). Significantly more children who were treated with a brace had returned to baseline activities by 4 weeks compared with those who were casted (80.8% vs 59.5%). Fifty-four percent of the casted children would have preferred the brace, but only 5.7% of children who received the brace would have preferred the cast. The cost-effectiveness acceptability curve was always >80%; therefore, the brace was cost-effective compared with the cast., Conclusions: The removable ankle brace is more effective than the cast with respect to recovery of physical function, is associated with a faster return to baseline activities, is superior with respect to patient preferences, and is also cost-effective.

Prophylactic ankle taping has been considered the mainstay of ankle injury prevention and has been used at all levels of competitive football. An alternative to taping is a semirigid ankle orthosis. This study prospectively compared the incidence of ankle sprains in high school football players during a single season, after randomization to either prophylactic bracing or taping of both ankles. Of 83 athletes followed up for an entire season, 6 ankle sprains occurred, 3 in each treatment group; and there was no statistically significant difference in the incidence of ankle sprains between the 2 groups. The time required to tape an athlete averaged 67 seconds per ankle, resulting in a total of 97 minutes per ankle during an entire season, and the average cost to tape each ankle during an entire season was greater than the cost of the commercially available brace. The projected cost savings for an athletic program using prophylactic bracing could be substantial when compared with the use of prophylactic taping of the ankle.

Background: The annual incidence of tennis elbow in the general population is high (1-3%). Tennis elbow often leads to limitation of activities of daily living and work absenteeism. Physiotherapy and braces are the most common treatments., Objectives: The hypothesis of the trial was that no difference exists in the cost effectiveness of physiotherapy, braces, and a combination of the two for treatment of tennis elbow., Methods: The trial was designed as a randomised controlled trial with intention to treat analysis. A total of 180 patients with tennis elbow were randomised to brace only (n = 68), physiotherapy (n = 56), or a combination of the two (n = 56). Outcome measures were success rate, severity of complaints, pain, functional disability, and quality of life. Follow up was at six, 26, and 52 weeks. Direct healthcare and non-healthcare costs and indirect costs were measured. Mean cost differences over 12 months were evaluated by applying non-parametric bootstrap techniques., Results: No clinically relevant or statistically significant differences were found between the groups. Success rate at 12 months was 89% in the physiotherapy group, 86% in the brace group, and 87% in the combination group. Mean total costs per patient were 2069 euros in the brace only group, 978 euros in the physiotherapy group, and 1256 euros in the combination group. The mean difference in total costs between the physiotherapy and brace group was substantial (1005 euros), although not significant. Cost effectiveness ratios and cost utility ratios showed physiotherapy to be the most cost effective, although this also was not statistically significant., Conclusion: No clinically relevant or statistically significant differences in costs were identified between the three strategies.

Background: Bracing after anterior cruciate ligament reconstruction is expensive and is not proven to prevent injuries or influence outcomes., Purpose: To determine whether postoperative functional knee bracing influences outcomes., Study Design: Prospective, randomized, multicenter clinical trial., Methods: One hundred volunteers from the 3 US service academies with acute anterior cruciate ligament tears were randomized into braced or nonbraced groups. Only those subjects with anterior cruciate ligament tears treated surgically within the first 8 weeks of injury were included. Patients with chondral injuries, significant meniscal tears, or multiple knee ligament injuries were excluded. Surgical procedures and the postoperative physical therapy protocols were identical for both groups. The braced group was instructed to wear an off-the-shelf functional knee brace for all cutting, pivoting, or jumping activities for the first year after surgery., Results: Ninety-five subjects were available with a minimum 2-year follow-up. There were no statistically significant differences between groups in knee stability, functional testing with the single-legged hop test, International Knee Documentation Committee scores, Lysholm scores, knee range of motion, or isokinetic strength testing. Two braced subjects had reinjuries, and 3 nonbraced subjects had reinjuries., Conclusions: In this young, active population, postoperative bracing does not appear to change the clinical outcomes after anterior cruciate ligament reconstruction.

The comparison of disparate interventions for the prevention and management of osteoarthritis (OA) is limited by the quality and quantity of published efficacy studies and the use of disparate measures for reporting clinical trial outcomes. The "transfer to utility" technique was used to translate published trial outcomes into a health-related quality-of-life (utility) scale, creating a common metric which supported comparisons between disparate interventions. Total hip replacement (THR) and total knee replacement (TKR) surgery were the most effective treatments and also highly cost-effective, at estimated cost per quality-adjusted life-year (QALY) of 7500 dollars for THR and 10000 dollars for TKR (best estimate). Other apparently highly cost-effective interventions were exercise and strength training for knee OA (< 5000 dollars/QALY), knee bracing, and use of capsaicin or glucosamine sulfate (< 10000 dollars/QALY). The cost per QALY estimates of non-specific and COX-2 inhibitor non-steroidal anti-inflammatory drugs were affected by treatment-related deaths and highly sensitive to the discounting of life-years lost. OA interventions that have been shown to be ineffective (eg, arthroscopy) are targets for redistribution of healthcare resources. OA interventions which lack efficacy studies (eg, prevention programs) require further research to assist priority setting. The application of the Health-sector Wide model to OA demonstrates its role as an evidence-based model that can be successfully applied to identify marginal interventions - those to be expanded and contracted to reduce the expected burden of disease, within current healthcare resources.

Objective: To collect information for the purpose of establishing starting points and possibilities for a cost-effectiveness analysis of screening for adolescent idiopathic scoliosis (AIS)., Design: Interviews, literature review, questionnaires, an estimation of costs and discussions with experts and involved parties., Method: Following an initial interview with 16 orthopaedic surgeons and school doctors a literature study into the efficacy of treatment was carried out regarding the years 1989-1999. The variation in current practice was delineated by means of a questionnaire sent to all 51 municipal health services in the Netherlands. The costs of screening and treatment were estimated on the basis of health insurance premiums and a municipal health service cost model. All of the results were presented to five methodological experts and finally the study results and the recommendations of the five methodological experts were evaluated during a meeting of persons especially invited for this purpose., Results: Screening for AIS was established to realise early diagnosis and treatment with a brace, so as to reduce unsatisfactory cosmetic outcomes and the need for surgery. Screening was performed using the bending test and was performed in 40/48 (83%) of the participating municipal health services. The overall costs of screening and treatment amount to 6 million euros per year. There was no convincing evidence that the screening programme was sufficiently sensitive and bracing sufficiently effective. Neither was there proof of the opposite. The following was recommended: obtain reliable data by carrying out a randomised controlled trial on the effectiveness of treating AIS with bracing in an early stage; carry out a case-control study combined with a retrospective patient follow-up study to evaluate the current screening practice; draw up a national standard for the screening of postural disorders in youth healthcare to ensure effective practice.

A retrospective review of social insurance claim files of male blue collar workers was conducted to compare the social insurance costs of percutaneous lumbar nucleotomy with standard lumbar discectomy ; 29 percutaneous nucleotomy procedures were matched with 58 standard discectomies all carried out between January 1992 and December 1994. It was concluded that a standard discectomy procedure results in significantly higher costs during hospitalisation with respect to surgery, anaesthesia and hospital stay. A percutaneous nucleotomy leads to a significantly higher outpatient expenditure especially in radiology and medical devices. The relative proportion of outpatient practitioner's visits and hospital stay costs was significantly higher for the standard discectomy whereas medical devices had a relatively higher share in outpatient expenditure for the percutaneous nucleotomy. In this population of 87 compensation claimants, the average social insurance costs did not significantly differ between the percutaneous nucleotomy and the standard discectomy.

The ankle joints of 14 healthy volunteers and 16 patients with unstable ankle joints were tested for their functional and proprioceptive capabilities. All of them were active athletes. Three tests were used: the single-leg stance test, the single-leg jumping course test, and the angle-reproduction test. The influence of three stabilization devices--the lace-on brace (Mikros), the stirrup brace (Aircast), and taping--on the proprioceptivity of stable and unstable ankle joints was evaluated. The scores of the single-leg jumping course test without any stabilizing device ("standard" category) ranged between 8.06 and 13.68 (10.65 + 1.29). In the Mikros (9.95 + 0.99) and Aircast (9.99 + 1.14) brace categories, as well as the tape bandage (10.27 + 0.81) category, better scores were achieved. The differences between "standard vs Mikros" and "standard vs Aircast" revealed a significant reduction of the scores with the orthoses (P < .01). The error rate in the single-leg stance test was within the range of 0 to 16 (5.12 + 2.85) for the standard category. It was lower for the Mikros (3.65 + 2.65) and Aircast (4.17 + 2.59) categories. The error rate was highest in the tape bandage group (5.79 + 3.53). There was a significant difference between "standard vs Mikros" and "standard vs Aircast" regarding injured and non-injured ankle joints (P < .01). The angle-reproduction test showed higher values for the standard (2.36 degrees + 0.97) category than the Mikros (1.46 degrees + 0.72), Aircast (1.62 degrees + 0.91), and taping (1.84 degrees + 0.41) categories. In the standard category, the reproduction error was lower when non-injured ankle joints (2.30 degrees + 1.04) were tested than when unstable ankle joints (2.44 degrees + 0.81) were tested, whereas in all other categories the reproduction error was higher in the group of non-injured joints. According to the literature, applying a prophylactic brace can prevent an estimated 30 ankle sprains per 1000 athletic exposures.

Sixty-six skeletally immature patients with idiopathic scoliosis were treated with a Prenyl brace and their results were analyzed. Fifty-three patients (80%) showed a satisfactory response. The best results were obtained in patients with lumbar curves and thoracolumbar curves less than 40 degrees. Advantages of this brace are simplicity of fabrication and fitting, patient comfort, patient acceptance and relatively low cost. The disadvantages of this brace are that it is less effective in thoracic curves in the upper thoracic spine, double major curves and kyphosis. It probably causes more significant chest restriction than the Milwaukee brace.