NCT03751618

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Clinique de la Sauvegarde · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Femoral Acetabular Impingement

Interventions

Type	Name	Description
PROCEDURE	Hip arthroscopy	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.

Timeline

• Start date: 2018-02-07
• Primary completion: 2021-03-01
• Completion: 2023-06-01
• First posted: 2018-11-23
• Last updated: 2023-09-13

Locations

1 site across 1 country: France