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

Femoral Acetabular Impingement Clinical Trial

— SUTURCAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03751618
• Other study ID #: 2017-CSV-001
• Status: Completed
• Phase: N/A
• Start date: February 7, 2018
• Est. completion date: June 1, 2023

Study information

• Verified date: November 2018
• Source: Clinique de la Sauvegarde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 1, 2023
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoral Acetabular Impingement

Intervention

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.

Locations

Country	Name	City	State
France	Clinique de la Sauvegarde	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Clinique de la Sauvegarde

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient reported outcomes (questionnaires)	HAGOS score	2 years
Secondary	patient reported outcomes (questionnaires)	modified Harris Hip Score	6 months
Secondary	patient reported outcomes (questionnaires)	iHOT-12	1 year