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

Not Applicable

Completed

• Conditions: Femoral Acetabular Impingement
• Interventions: Procedure: Hip arthroscopy

• Registration Number: NCT03751618
• Lead Sponsor: Clinique de la Sauvegarde

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

Study Timeline

• Study Start: 2018-02-07
• Study First Submitted: 2018-07-03
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-23
• Primary Completion: 2021-03-01
• Study Completion: 2023-06-01
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capsular suture	Hip arthroscopy	Capsular suture at the end of hip arthroscopy
No capsular suture	Hip arthroscopy	No capsular suture at the end of hip arthroscopy

Primary Outcome Measures

Name	Time	Method
patient reported outcomes (questionnaires)	2 years	HAGOS score

Secondary Outcome Measures

Name	Time	Method
patient reported outcomes (questionnaires)	1 year	iHOT-12

Trial Locations

Locations (1)

Clinique de la Sauvegarde; 🇫🇷 Lyon, France