Clinical trial NCT03751618: Evaluation of Non Inferiority of Non Capsular Suture in Femoroacetabular Impingement Arthroscopic Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Acetabular Impingement
Keywords: Hip arthroscopy
capsular suture
Femoral Acetabular Impingement
Lead sponsor: Clinique de la Sauvegarde
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, monocentric, randomized, double blind study
Primary purpose: OTHER

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: patient reported outcomes (questionnaires)
timeFrame: 2 years
Secondary outcomes:
measure: patient reported outcomes (questionnaires)
timeFrame: 6 months
measure: patient reported outcomes (questionnaires)
timeFrame: 1 year
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de la Sauvegarde
Study officials:
References: