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Capsular Repair in FAI Impingement Surgery

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ClinicalTrials.gov Identifier: NCT02990234
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The Investigator's hypothesis is that capsular repair (after CAM or mixed Femoroacetabular Impingement (FAI) surgery) requiring moderate capsulotomy, would result in similar patient outcomes in the short, mid and long term, both clinically and radiographically, compared to those without capsular repair. The objective of this clinical trial is to evaluate the clinical efficacy with regards to pain, range of motion and return to work and activities of daily living. Secondary objective is to evaluate radiographic characteristics between both groups.

Condition or disease Intervention/treatment Phase
Hip Injuries Procedure: Capsular Repair Procedure: No Capsular Repair Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Efficacy of Capsular Repair in Arthroscopic Femoroacetabular
Actual Study Start Date : March 2014
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Capsular Repair
Capsular Repair arm. The first hip is randomized, opposite treatment on second hip. One Hip will receive the capsular repair while the other hip will not.
Procedure: Capsular Repair
Placebo Comparator: No Capsular Repair
Placebo arm. One hip is randomized to capsular repair while the other hip has no capsular repair.
Procedure: No Capsular Repair



Primary Outcome Measures :
  1. Change in iHOT Version 12 [ Time Frame: Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years ]

Other Outcome Measures:
  1. Change in Marx activity score [ Time Frame: Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years ]
  2. Change in Range of Motion [ Time Frame: Baseline, 14days, 6weeks, 12weeks, 6months, 1Year, 2Years ]
  3. Change in X-rays [ Time Frame: 6weeks, 6months, 1Year ]
    XR will be used for initial evaluation and for post op resection assessment and long-term OA changes. X-rays will be done post-operatively at 6 weeks, 6 months and 1 year time-frames. All these x-rays are normally performed as standard of care.

  4. Change in MRI [ Time Frame: 6weeks, 6months ]
    MRI will be conducted at 6 weeks and 6 months post op to evaluate capsular healing status (primary radiological outcome measure), intra articular adhesions, extra articular scarring, labrum/cartilage status and resection assessment. This MRI will be paid by department funds.



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Ages Eligible for Study:   16 Years to 51 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients aged between 16-51 years of age.
  2. Healthy patients undergoing hip arthroscopy due to Cam or mixed FAI
  3. No major osteoarthritic (OA) changes according to X-Ray and surgery observation (Tonnis 0-1)
  4. No previous hip surgery
  5. No other influential disabilities in lower limbs
  6. No chronic use of NSAID, analgesics, steroids or chemotherapy drugs
  7. Base line activity level (Tegner 3 and above)

Exclusion Criteria:

  1. Patients with concomitant disease that may affect joints
  2. Patients with major ligamentous laxity
  3. Patients who have undergone only minor vertical capsulotomy (as in small pincer only lesions)
  4. Patients with extreme range of motion needs (such as ballet dancers)
  5. Patients suffering from connective tissue disease
  6. Patients suffering from bilateral symptomatic FAI that are being operated on for their first hip
  7. Patients with relative or proven dysplastic hip determined by center edge angle and/or extreme version abnormalities as measured on apical CT/MR cuts and pelvic XR
  8. Patients who needed Ilio-Psoas release
  9. Patients whose cartilage hip status was defined as advanced OA during surgery
  10. Patients who following surgery would be instructed to avoid full weight bearing on the operated hip for more than 4 weeks
  11. Concomitant use of PRP (platelet rich plasma) or hyaluronic acid during the surgical procedure
  12. Patients with preoperative hip stiffness

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): NCT02990234


Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Omer Mei-Dan, MD University of Colorado, Denver
Publications:
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02990234    
Other Study ID Numbers: 13-2310
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
Capsular Repair
FAI
Hip
Additional relevant MeSH terms:
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Hip Injuries
Wounds and Injuries