Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 56 for:    Recruiting, Not yet recruiting, Available Studies | Arthroscopy

CREST: Capsular Repair During Hip Arthroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03372564
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Aaron Krych, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Hip Arthroscopy Procedure: Hip Capsule Repair Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CREST: A Randomized Controlled Trial Comparing Inter-portal Hip Capsular Repair vs. No Repair Following Hip Arthroscopy
Actual Study Start Date : November 7, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: Hip Capsule Repair
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
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).

No Intervention: No Hip Capsule Repair (Control)
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.



Primary Outcome Measures :
  1. Hip Function [ Time Frame: Baseline, 6 months ]
    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.


Secondary Outcome Measures :
  1. Hip ROM [ Time Frame: Baseline, 6 months ]
    Hip range of motion will be assessed by a blinded examiner. The change in degrees of range of motion from baseline to 6 month examination will be assessed.

  2. Pain [ Time Frame: Baseline, 6 months ]
    The change in pain scores will be assessed using VAS (visual analog scale) pain score, analyzing the change in units of measure between the baseline and 6 month time-points.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Criteria: Inclusion Criteria:

  1. Adults aged 18 to 50 (men or women)
  2. Hip pain for greater than 3 months that has failed non-operative treatment (physical therapy, NSAIDS, rest)
  3. FAI documented on X-Ray or Magnetic resonance imaging (MRI) or magnetic resonance arthrogram (MRA)
  4. Intraoperative labral repair or intact labrum
  5. Informed consent from the participant
  6. Ability to comprehend and speak English and the study design.

Pre-operative exclusion criteria are the following:

  1. Hypermobility/Ehlers-Danlos syndrome
  2. Evidence of hip dysplasia (Center edge angle less than 20)
  3. Previous surgery or trauma of the affected hip
  4. Severe acetabular deformities such as circumferential labral ossification, acetabular protrusion20
  5. Inflammatory/ autoimmune disease
  6. Immunosuppressant medication
  7. Significant medical co-morbidities such as uncontrolled diabetes, hypertension, congestive heart failure, etc.
  8. Severe mental or physical disability requiring assistance in daily living
  9. History of pediatric hip disease with previous operation (developmental dysplasia, Legg-Calve-Perthes, Slipped capital femoral epiphysis)
  10. Presence of advanced hip osteoarthritis (Tonnis grade 2 or 3)18
  11. Worker's compensation status
  12. Intraoperative microfracture, or other procedure that would alter postoperative rehabilitation
  13. Intraoperative labral debridement or labral reconstruction
  14. Peri-trochanteric or deep gluteal space arthroscopy
  15. Avascular necrosis

Intra-operative exclusion criteria are the following:

  1. Labral debridement
  2. Labral reconstruction
  3. Poor quality capsular tissue
  4. Hyperlaxity based on excessive subluxation of the joint greater than 2 cm with standard 50 pounds of traction
  5. Concomitant procedures such as MFX and iliopsoas lengthening will be included

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372564


Contacts
Layout table for location contacts
Contact: Jennifer Krogman 507-538-3562 krogman.jennifer@mayo.edu

Locations
Layout table for location information
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Jason Alben       Alben.Jason@mayo.edu   
Contact: Brynn Goldberg       goldberg.brynn@mayo.edu   
Principal Investigator: David Hartigan         
United States, Illinois
American Hip Institute Recruiting
Westmont, Illinois, United States, 60559
Contact: Joe Ornelas       drdomb@americanhipinstitute.org   
Principal Investigator: Benjamin Domb         
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jennifer Krogman    507-538-3562    krogman.jennifer@mayo.edu   
Principal Investigator: Aaron J Krych         
Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Aaron J Krych Mayo Clinic

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Aaron Krych, Professor of Orthopedics, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03372564     History of Changes
Other Study ID Numbers: 16-009462
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No