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

NCT03751618 | Completed

• 1 other identifier: 2017-CSV-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Acetabular Impingement

Keywords

Hip arthroscopy; capsular suture; Femoral Acetabular Impingement

Outcome Measures

Primary Outcomes (1)

• patient reported outcomes (questionnaires)

  HAGOS score

  2 years

Secondary Outcomes (2)

• patient reported outcomes (questionnaires)

  6 months

• patient reported outcomes (questionnaires)

  1 year

Study Arms (2)

Capsular suture

EXPERIMENTAL

Capsular suture at the end of hip arthroscopy

Procedure: Hip arthroscopy

No capsular suture

ACTIVE COMPARATOR

No capsular suture at the end of hip arthroscopy

Procedure: Hip arthroscopy

Interventions

Hip arthroscopy PROCEDURE

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.

Capsular suture; No capsular suture

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique de la Sauvegarde: lead

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, monocentric, randomized, double blind study

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: November 23, 2018
• Study Start: February 7, 2018
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2023
• Last Updated: September 13, 2023

Record last verified: 2018-11

Locations

FR (1)