Capsular Repair in FAI Impingement Surgery

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy of Capsular Repair in Arthroscopic Femoroacetabular

Conditions
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Hip Injuries

Intervention / Treatment
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* Procedure: Capsular Repair
* Procedure: No Capsular Repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged between 16-51 years of age. Healthy patients undergoing hip arthroscopy due to Cam or mixed FAI No major osteoarthritic (OA) changes according to X-Ray and surgery observation (Tonnis 0-1) No previous hip surgery No other influential disabilities in lower limbs No chronic use of NSAID, analgesics, steroids or chemotherapy drugs Base line activity level (Tegner 3 and above) Exclusion Criteria: Patients with concomitant disease that may affect joints Patients with major ligamentous laxity Patients who have undergone only minor vertical capsulotomy (as in small pincer only lesions) Patients with extreme range of motion needs (such as ballet dancers) Patients suffering from connective tissue disease Patients suffering from bilateral symptomatic FAI that are being operated on for their first hip 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 Patients who needed Ilio-Psoas release Patients whose cartilage hip status was defined as advanced OA during surgery Patients who following surgery would be instructed to avoid full weight bearing on the operated hip for more than 4 weeks Concomitant use of PRP (platelet rich plasma) or hyaluronic acid during the surgical procedure Patients with preoperative hip stiffness

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 51 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Capsular Repair<br>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<br> <br> |
| Placebo Comparator: No Capsular Repair<br>Placebo arm. One hip is randomized to capsular repair while the other hip has no capsular repair. | Procedure: No Capsular Repair<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in iHOT Version 12 |  | Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Capsular Repair, FAI, Hip