Status:
ACTIVE_NOT_RECRUITING
CREST: Capsular Repair During Hip Arthroscopy
Lead Sponsor:
Mayo Clinic
Conditions:
Hip Arthroscopy
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 funct...
Detailed Description
Background Femoroacetabular impingement (FAI) is a well-described condition that causes hip pain in young to middle age adults. Cross sectional studies have estimated that the prevalence of hip imping...
Eligibility Criteria
Inclusion
- Criteria: 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.
- Pre-operative exclusion criteria are the following:
- 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
- Inflammatory/ autoimmune disease
- Immunosuppressant medication
- Significant medical co-morbidities such as uncontrolled diabetes, hypertension, congestive heart failure, etc.
- Severe mental or physical disability requiring assistance in daily living
- History of pediatric hip disease with previous operation (developmental dysplasia, Legg-Calve-Perthes, Slipped capital femoral epiphysis)
- Presence of advanced hip osteoarthritis (Tonnis grade 2 or 3)18
- Worker's compensation status
- Intraoperative microfracture, or other procedure that would alter postoperative rehabilitation
- Intraoperative labral debridement or labral reconstruction
- Peri-trochanteric or deep gluteal space arthroscopy
- Avascular necrosis
- Intra-operative exclusion criteria are the following:
- Labral debridement
- Labral reconstruction
- Poor quality capsular tissue
- Hyperlaxity based on excessive subluxation of the joint greater than 2 cm with standard 50 pounds of traction
- Concomitant procedures such as MFX and iliopsoas lengthening will be included
Exclusion
Key Trial Info
Start Date :
November 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2040
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03372564
Start Date
November 7 2017
End Date
December 1 2040
Last Update
April 24 2025
Active Locations (3)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
American Hip Institute
Westmont, Illinois, United States, 60559
3
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905