CREST: Capsular Repair During Hip Arthroscopy (NCT03372564) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
CREST: Capsular Repair During Hip Arthroscopy
United States250 participantsStarted 2017-11-07
Plain-language summary
Capsular REpair randomiSed controlled Trial (CREST) is a multi-center, randomized controlled trial with a sample size of 240 patients (120 patients in each group). The primary outcome measure is functional outcome as measured by the change in Hip Outcome Score at 6 months with secondary outcomes being hip range of motion, i-HOT 12, overall satisfaction, and VAS. Patients are stratified based on gender. Patients, outcome assessors, and data analysts are blinded to surgical allocation. Using an intention-to-treat approach, outcome analyses will be performed using an analysis of covariance and descriptive statistics.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Adults aged 18 to 50 (men or women)
✓. Hip pain for greater than 3 months that has failed non-operative treatment (physical therapy, NSAIDS, rest)
✓. FAI documented on X-Ray or Magnetic resonance imaging (MRI) or magnetic resonance arthrogram (MRA)
✓. Intraoperative labral repair or intact labrum
✓. Informed consent from the participant
✓. Ability to comprehend and speak English and the study design.
Exclusion criteria
✕. Hypermobility/Ehlers-Danlos syndrome
✕. Evidence of hip dysplasia (Center edge angle less than 20)
✕. Previous surgery or trauma of the affected hip
✕. Severe acetabular deformities such as circumferential labral ossification, acetabular protrusion20