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Clinical Trials/NCT03751618
NCT03751618
Completed
Not Applicable

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

Clinique de la Sauvegarde1 site in 1 country90 target enrollmentFebruary 7, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Femoral Acetabular Impingement
Sponsor
Clinique de la Sauvegarde
Enrollment
90
Locations
1
Primary Endpoint
patient reported outcomes (questionnaires)
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
February 7, 2018
End Date
June 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

patient reported outcomes (questionnaires)

Time Frame: 2 years

HAGOS score

Secondary Outcomes

  • patient reported outcomes (questionnaires)(1 year)

Study Sites (1)

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