Evaluation of Non Inferiority of Non Capsular Suture in Femoroacetabular Impingement Arthroscopic Treatment (SUTURCAP)

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

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.

Study Overview

• Status: Completed
• Conditions: Femoral Acetabular Impingement
• Intervention / Treatment: Procedure: Hip arthroscopy

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69009
    • Clinique de la Sauvegarde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capsular suture; Capsular suture at the end of hip arthroscopy	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.
Active Comparator: No capsular suture; No capsular suture at the end of hip arthroscopy	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clinique de la Sauvegarde

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2018
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Hip arthroscopy; capsular suture; Femoral Acetabular Impingement
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Femoracetabular Impingement
• Other Study ID Numbers: 2017-CSV-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No