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

C

Clinique de la Sauvegarde

Status

Completed

Conditions

Femoral Acetabular Impingement

Treatments

Procedure: Hip arthroscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT03751618
2017-CSV-001

Details and patient eligibility

About

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.

Full 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

Enrollment

90 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 2 patient groups

Capsular suture
Experimental group
Description:
Capsular suture at the end of hip arthroscopy
Treatment:
Procedure: Hip arthroscopy
No capsular suture
Active Comparator group
Description:
No capsular suture at the end of hip arthroscopy
Treatment:
Procedure: Hip arthroscopy

Trial contacts and locations

1

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Central trial contact

Johanne Beuvelot, PhD; Nicolas Bonin, MD

Data sourced from clinicaltrials.gov

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