CREST: Capsular Repair During Hip Arthroscopy

NCT03372564 | Active Not Recruiting

• 1 other identifier: 16-009462
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Hip Arthroscopy

Outcome Measures

Primary Outcomes (1)

• Hip Function

  The main outcome assessed will be hip function including change in percentage of Hip outcome score (HOS score) from baseline to 6 month follow-up. The subscale of ADL (activities of daily living) and Sport will be utilized. each HOS subscale is calculated from 0 to 100%, with 100% being the best score.

  Baseline, 6 months

Secondary Outcomes (2)

• Hip ROM

  Baseline, 6 months

• Visual Analog Pain Score Progression

  Baseline, 6 months

Study Arms (2)

Hip Capsule Repair

EXPERIMENTAL

Patients in the intervention group (Hip capsule repair) will undergo initial diagnostic arthroscopy of the hip. Two to three standard portals (anterolateral, mid anterior, distal antero-lateral, posterolateral) will be used during the entire procedure to assess and treat the patient. After establishing standard portals, an interportal capsulotomy is completed to allow for complete evaluation of the central compartment of the hip. In the central compartment, significant and obvious pathologies will be addressed accordingly. Following addressing central compartment pathologies, cam impingement type lesions in the peripheral compartment will be treated. Once all pathologies are addressed, the interportal capsulotomy10 will be repaired by using simple interrupted sutures with absorbable suture (Number 1 Vicryl). Three to four simples sutures will be placed and tied using arthroscopic technique.

Procedure: Hip Capsule Repair

No Hip Capsule Repair (Control)

NO INTERVENTION

Patients in the control group (no hip capsule repair) have the same portals utilized and will have the same interportal capsulotomy performed. They will have all central and peripheral compartment pathologies addressed in the same way that the study group does. At the conclusion of the case, the hip capsule will be left open and not repaired.

Interventions

Hip Capsule Repair PROCEDURE

In the central compartment, significant and obvious pathologies will be addressed accordingly. Following addressing central compartment pathologies, cam impingement type lesions in the peripheral compartment will be treated. Once all pathologies are addressed, the interportal capsulotomy10 will be repaired by using simple interrupted sutures with absorbable suture (Number 1 Vicryl).

Hip Capsule Repair

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

American Hip Institute

Westmont, Illinois, 60559, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (4)

• Domb BG, Stake CE, Finley ZJ, Chen T, Giordano BD. Influence of capsular repair versus unrepaired capsulotomy on 2-year clinical outcomes after arthroscopic hip preservation surgery. Arthroscopy. 2015 Apr;31(4):643-50. doi: 10.1016/j.arthro.2014.10.014. Epub 2014 Dec 16.

  PMID: 25530511 BACKGROUND

• Frank RM, Lee S, Bush-Joseph CA, Kelly BT, Salata MJ, Nho SJ. Improved outcomes after hip arthroscopic surgery in patients undergoing T-capsulotomy with complete repair versus partial repair for femoroacetabular impingement: a comparative matched-pair analysis. Am J Sports Med. 2014 Nov;42(11):2634-42. doi: 10.1177/0363546514548017. Epub 2014 Sep 11.

  PMID: 25214529 BACKGROUND

• Wylie JD, Beckmann JT, Maak TG, Aoki SK. Arthroscopic Capsular Repair for Symptomatic Hip Instability After Previous Hip Arthroscopic Surgery. Am J Sports Med. 2016 Jan;44(1):39-45. doi: 10.1177/0363546515608162. Epub 2015 Sep 29.

  PMID: 26419897 RESULT

• Chahal J, Van Thiel GS, Mather RC 3rd, Lee S, Song SH, Davis AM, Salata M, Nho SJ. The Patient Acceptable Symptomatic State for the Modified Harris Hip Score and Hip Outcome Score Among Patients Undergoing Surgical Treatment for Femoroacetabular Impingement. Am J Sports Med. 2015 Aug;43(8):1844-9. doi: 10.1177/0363546515587739. Epub 2015 Jun 15.

  PMID: 26078452 RESULT

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Papaverine; Wound Healing

Intervention Hierarchy (Ancestors)

Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Opiate Alkaloids; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Regeneration; Biological Phenomena

Study Officials

• Aaron J Krych

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopedics

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 13, 2017
• Study Start: November 7, 2017
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2040
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)