Evaluation of Non Inferiority of Non Capsular Suture in Femoroacetabular Impingement Arthroscopic Treatment

Study Overview
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Brief Summary
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Since last past decade, arthroscopic hip surgery proved its efficacy in femoroacetabular impingement treatment. However, no consensus exist concerning capsular suture or not. According to capsular incision size, articular instability can persist if no suture is performed. In contrast, tightly suture can cause post-operative joint stiffness. This study aims to evaluate the non inferiority of non capsular suture after hip arthroscopy treatment of cam or mixed-type femoroacetabular impingement, without hip dysplasia, after 2 years follow-up.

Detailed Description
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Main Objective : Non inferiority evaluation of non capsular suture after hip arthroscopy treatment of cam or mixed-type femoroacetabular impingement, without hip dysplasia, after 2 years follow-up. The primary study endpoint is the patient reported outcomes (HAGOS score; iHOT-12 and MHHS) at 2 years follow-up. Secundary objectives : Clinical results at 6 month and 1 year follow-up Specific complications occuring and frequences Patient quality of life, The return to sport, Sport level after surgery compare to sport level before surgery Pain

Official Title
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Prospective Study, Monocentric, Randomized, Double Blind Evaluating the Non Inferiority of Non Capsular Suture in Arthroscopic Treatment of Cam or Mixed-type Femoroacetabular Impingement Without Hip Dysplasia

Conditions
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Femoral Acetabular Impingement

Intervention / Treatment
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* Procedure: Hip arthroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient < 18 years old Patient who can be followed for 2 years Patient with confirmed diagnostic of femoroacetabular impingement came or mixed-types, without dysplasia and with VCE angle > 25°, without prearthrosic lesion and Tonnis 0 ou Tonnis 1, radiographic assement Patient must sign an informed consent form indicating that he or she understands the purpose of procedure required for the study and accepts to participate in the study. Patient affiliated to a social security system Exclusion Criteria: Patient with no wittren informed consent Patient presenting osteoarthritis (Tonnis stage 2) or only pincer impingement Hyperlaxity Dysplasia (VCE <25°) Patient already underwent hip arthroscopy Patient already underwent previous hip surgery Patient needing bilateral hip arthroscopy < 2 years Persons deprived of their freedom or under guardianship or incapable of giving consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, monocentric, randomized, double blind study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capsular suture<br>Capsular suture at the end of hip arthroscopy | Procedure: Hip arthroscopy<br>* Suture will be realized with two simple suture knots (non resorbable suture material). These suture knots will be performed at the end of hip arthroscopy. Correct capsular suture will be controlled under arthroscopy video. Patients randomized in control arm will not received capsular suture at the end of the procedure.<br>|
| Active Comparator: No capsular suture<br>No capsular suture at the end of hip arthroscopy | Procedure: Hip arthroscopy<br>* Suture will be realized with two simple suture knots (non resorbable suture material). These suture knots will be performed at the end of hip arthroscopy. Correct capsular suture will be controlled under arthroscopy video. Patients randomized in control arm will not received capsular suture at the end of the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient reported outcomes (questionnaires) | HAGOS score | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient reported outcomes (questionnaires) | modified Harris Hip Score | 6 months | 
| patient reported outcomes (questionnaires) | iHOT-12 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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capsular suture, Hip arthroscopy, Femoral Acetabular Impingement