IMBRACE: Can a specialised hip BRACE alleviate symptoms of hip IMpingement? A randomised controlled trial comparing a hip brace plus usual care to usual care alone.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2017
INTERVENTION: Participants randomly allocated into the ‘hip brace’ arm will receive their usual non‐surgical care, plus will be provided with a hip brace, designed by Ossur, to wear for the six weeks of the study. The hip brace comprises an elastic strap with loading mechanism that wraps around the affected leg, and a compressive pelvic belt that wraps around the pelvis and gluteal region. Participants will attend an appointment with an orthotist or trained research assistant, during which their hip brace will be fitted in an appointment lasting appproximately one hour. Participants will be advised to wear the hip brace for approximately two hours per day in the first week of the study, approximately four hours per day in the second week, and four hours or more in the third week of the study and thereafter (there is no maximum amount of time that participants are permitted to wear the brace each day). After one week, participants will attend a follow up fitting appointment (approx. 30 mins duration), during which it will be checked that their hip brace fits well and they are wearing it correctly. Participants will be allowed to keep their hip brace following the six weeks of the study. Participants in the treatment group will also be asked via questionnaire about the additional treatments they access during the six weeks of the study. All participants in the treatment group will be referred for an EOS scan at baseline. CONDITION: Acetabular labral tear Femoroacetabular impingement (FAI) PRIMARY OUTCOME: Change in hip‐specific health‐related quality of life, as measured by changes in score on the international Hip Outcome Tool (iHOT‐33). SECONDARY OUTCOME: Acetabular version, measured on EOS scan Alpha angle, measured on EOS scan ; Change in hip symptoms as assessed by the Copenhagen Hip and Groin Outcome Score (HAGOS). Change in hip‐specific health‐related quality of life, as measured by changes in score on the international Hip Outcome Tool (iHOT‐33). FAI brace tolerability as reflected by QUEST survey scores (Quebec User Evaluation of Satisfaction with assistive Technology survey). Femoral neck shaft angle, measured on EOS scan Femoral version, measured on EOS scan ; ; Lateral centre edge angle, measured on EOS scan ; Leg length inequality, measured as difference between femoral plus tibial lengths between the right and left legs on EOS scans. Pelvic tilt measured on EOS scans in postures of standing, sitting, and hip flexion. INCLUSION CRITERIA: Inclusion criteria for hip brace study: * Age >18 years * Symptoms of hip pain ‐ patients may also have symptoms of clicking, catching or giving way; * Patient has been diagnosed with symptomatic femoroacetabular impingement OR an acetabular labral tear causing hip symptoms by a study orthopaedic surgeon. * The patient is able to give written informed consent and to participate fully in the interventions and follow‐up procedures. Inclusion criteria for asymptomatic comparator EOS scans: * Over 18 years of age * Willing to have EOS scan
Epistemonikos ID: 8b9f1cb4996c7901af20236600079ed07292417c
First added on: Aug 23, 2024