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Completed

NCT Number: NCT03751618

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

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.

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Key information

Conditions

Femoral Acetabular Impingement Femoracetabular Impingement Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique de la Sauvegarde

Lyon, 69009, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. patient reported outcomes (questionnaires)

    Time frame: 2 years

    HAGOS score

Secondary outcomes

  1. patient reported outcomes (questionnaires)

    Time frame: 6 months

    modified Harris Hip Score

  2. patient reported outcomes (questionnaires)

    Time frame: 1 year

    iHOT-12

Sponsors and collaborators

Lead sponsor

Clinique de la Sauvegarde

Other

Registry information

Official study 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

Acronym: SUTURCAP

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Nov 23, 2018
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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