Can a Hip Brace Improve Short-Term Hip-Related Quality of Life for People With Femoroacetabular Impingement and Acetabular Labral Tears: An Exploratory Randomized Trial.

OBJECTIVES: To examine whether a hip brace can improve hip health quality-of-life (QoL) and is well-tolerated in people with femoroacetabular impingement syndrome (FAIS) or symptomatic labral tears after 6 weeks of wear. DESIGN: Parallel, two-arm, exploratory randomized trial. SETTING: Hospital and private clinics of orthopaedic surgeons. PARTICIPANTS: Individuals >18 years with FAIS or labral tears. INTERVENTIONS: Usual conservative care versus usual conservative care plus a hip brace. MAIN OUTCOMES: Patient-reported outcomes were assessed with the International Hip Outcome Tool (iHOT-33), and Copenhagen Hip and Groin Outcome Scores (HAGOS). Brace acceptability was measured using the Quebec User Evaluation of Satisfaction with Assistive Technology survey. Independent t-tests assessed between-group differences. RESULTS: Thirty-eight participants were recruited, 19 each group, 60% women, mean age 39.3 ± 11.8 years, body mass index 25.3 ± 4.4 kg/m2, iHOT-33 36.6 ± 24.8. Three participants dropped out (one usual care, 2 braced). The mean between-group difference for iHOT-33 was 19.4 (95% confidence interval [CI] 1.68-37.06, P = 0.03) favoring the brace. There were improvements in most HAGOS subscale scores favoring the brace. Issues with brace tolerability for some participants were perceived comfort and effectiveness. Three brace-related adverse events were reported. CONCLUSION: Between-group differences favored the braced group for hip health QoL, pain, symptoms, and function. Although these were promising results, the CIs for the estimates were wide, the small sample size likely a contributing factor. Our results suggest that further investigation of the brace is warranted, we calculated sample sizes and made recommendations for the design of a future trial.

Evaluation of placebo fidelity and trial design methodology in placebo-controlled surgical trials of musculoskeletal conditions: a systematic review.

ABSTRACT: The number of placebo surgical trials on musculoskeletal conditions is increasing, but little is known about the quality of their design and methods. This review aimed to (1) assess the level of placebo fidelity (ie, degree to which the placebo control mimicked the index procedure) in placebo trials of musculoskeletal surgery, (2) describe the trials' methodological features using the adapted Applying Surgical Placebo in Randomised Evaluations (ASPIRE) checklist, and (3) describe each trial's characteristics. We searched 4 electronic databases from inception until February 18, 2021, for randomised trials of surgery that included a placebo control for any musculoskeletal condition. Protocols and full text were used to assess placebo fidelity (categorised as minimal, low, or high fidelity). The adapted 26-item ASPIRE checklist was also completed on each trial. PROSPERO registration number: CRD42021202131. A total of 30,697 studies were identified in the search, and 22 placebo-controlled surgical trials of 2045 patients included. Thirteen trials (59%) included a high-fidelity placebo control, 7 (32%) used low fidelity, and 2 (9%) minimal fidelity. According to the ASPIRE checklist, included trials had good reporting of the "rationale and ethics" (68% overall) and "design" sections (42%), but few provided enough information on the "conduct" (13%) and "interpretation and translation" (11%) of the placebo trials. Most trials sufficiently reported their rationale and ethics, but interpretation and translation are areas for improvement, including greater stakeholder involvement. Most trials used a high-fidelity placebo procedure suggesting an emphasis on blinding and controlling for nonspecific effects.

A critical appraisal of clinical practice guidelines for the treatment of lumbar spinal stenosis.

OBJECTIVE: The aim of the review was to appraise clinical practice guidelines and their recommendations for the treatment of lumbar spinal stenosis. METHODS: PubMed, Medline, CINAHL, Embase, and Cochrane Central Register of Controlled Trials were searched up until 25/01/2020 for clinical practice guidelines on the management of lumbar spinal stenosis with a systematic process to generate recommendations and were publicly available. RESULTS: Ten guidelines were included, with a total of 76 recommendations for the treatment of lumbar spinal stenosis. Only 4 of the 10 guidelines were of satisfactory methodological quality according to the AGREE II instrument. Around three-quarters of recommendations (72.4%) were presented with poor evidence, with the remaining 21 presenting (27.6%) fair evidence. No recommendation presented good evidence. Recommendations were made on four types of interventions: surgery, injections, medications, and other nonsurgical treatments, with supporting evidence similar for all four treatment types. Positive recommendations were more common for injections (12/13=92.3%) and surgery (10/15=66%) than for nonsurgical treatments (6/21=28.6%) or medications (1/27=3.75%). CONCLUSIONS: Ten guidelines on the management of lumbar spinal stenosis were identified in the systematic review, but only four were of adequate methodological quality. While the evidence underpinning the various types of interventions was similar, guidelines tended to endorse surgery and injections but not nonsurgical interventions and medicines. These results support the need for greater rigor and inclusion of steps to minimize bias in the production of guidelines.

Observational study of the impact of an individualized multidisciplinary chronic care program for hip and knee osteoarthritis treatment on willingness for surgery.

AIM: To determine the impact of an osteoarthritis-specific multidisciplinary conservative care program (OACCP) on willingness for surgery (WFS) and to identify changes and factors in our cohort that influence and predict willingness for surgery. METHODS: Consecutive OACCP participants with hip or knee OA, with WFS (willing, unsure or unwilling) data for at least two appointments were included. The proportions of unwilling versus willing/unsure patients at baseline and last appointment were compared using McNemar's test. Logistic regression was used to analyze baseline age, gender, main language, educational status, living situation, number of comorbidities, index joint, non-index joint osteoarthritis, completion of program, baseline and change in pain, function, depression, body mass index and 6-min walk test (6MWT) for association with changing WFS. RESULTS: At baseline 203/409 were unwilling for surgery while by final appointment 234/409 were unwilling (P = 0.002). Of the 206 initially willing/unsure participants, 63/206 (30.6%) became unwilling by final appointment. Index joint, completion of program, baseline and change in pain, self-reported function and 6MWT were independently associated with becoming unwilling. Final model from multivariate logistic regression analysis regarding becoming unwilling included baseline pain (P < 0.001), change in pain (P < 0.001), completion of program (P < 0.001) and age (P = 0.004). CONCLUSION: A conservative OA-specific treatment program that improves pain and function can reduce willingness for surgery among participants with hip or knee OA. The strongest determinants of this reduction in willingness were baseline and change in pain, completion of the program and participant age.

Effectiveness of knee bracing in osteoarthritis: pragmatic trial in a multidisciplinary clinic.

AIM: Assessing the effectiveness of bracing treatment for tibiofemoral osteoarthritis (OA) and patellofemoral OA in patients with knee OA. METHOD: This study was conducted within the Osteoarthritis Chronic Care Program (OACCP), a 52-week multidisciplinary non-operative program for OA patients. All participants had symptomatic, radiographic knee OA. Knee bracing with Ossur Unloader One and Tru-pull Lite was offered for participants with medial/lateral tibiofemoral and patellofemoral OA, respectively. Participants were assessed at weeks 0, 12, 26 and 52. The primary outcome was knee pain and function at week 52, as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain and activities of daily living (ADL) scores. Linear regression models were used to compare effectiveness for pain and function between three groups (patellofemoral bracing, tibiofemoral bracing and no bracing). RESULT: There were 204 participants; 50 assigned patellofemoral bracing, 86 tibiofemoral bracing and 68 with no bracing. Mean baseline KOOS pain score was 52.9, 41.7 and 43.3 (0-100 scale where 100 represents normal) and mean baseline KOOS ADL score was 55.8, 43.7 and 43.1 for the three groups, respectively. Significant improvements were found in each group at week 52 for KOOS pain score and KOOS ADL. There was no significant difference in KOOS pain (P = 0.12) and ADL score (P = 0.13) at week 52 between the three brace types after adjusting for baseline variables. CONCLUSION: A multidisciplinary non-operative program improved pain and function in persons with patellofemoral and tibiofemoral OA. However, wearing a patellofemoral or a tibiofemoral brace did not appear to provide additional benefits.