CREST: Capsular Repair During Hip Arthroscopy

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adults aged 18 to 60 (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 protrusion.
  • 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).
  • 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.
  • MFX procedures that would change post-op rehabilitation are excluded.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aaron Krych, M.D.

Closed for enrollment

Contact information:

Jennifer Krogman

(507)538-3562

Krogman.Jennifer@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Aaron Krych, M.D.

Closed for enrollment

Contact information:

Brynn Goldberg M.S.N., R.N.

(480)342-2762

goldberg.brynn@mayo.edu

More information

Publications

  • The primary objective of this study was to determine whether capsular management technique influences clinical outcomes at a minimum of 2 years after arthroscopic hip preservation surgery. Read More on PubMed
  • Hip capsular management after hip arthroscopic surgery for femoroacetabular impingement (FAI) is controversial. Read More on PubMed