Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03751618
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Clinique de la Sauvegarde

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.


Condition or disease Intervention/treatment Phase
Femoral Acetabular Impingement Procedure: Hip arthroscopy Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, monocentric, randomized, double blind study
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official 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
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : July 7, 2019
Estimated Study Completion Date : July 7, 2021

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.





Primary Outcome Measures :
  1. patient reported outcomes (questionnaires) [ Time Frame: 2 years ]
    HAGOS score


Secondary Outcome Measures :
  1. patient reported outcomes (questionnaires) [ Time Frame: 6 months ]
    modified Harris Hip Score

  2. patient reported outcomes (questionnaires) [ Time Frame: 1 year ]
    iHOT-12



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751618


Contacts
Layout table for location contacts
Contact: Nicolas Bonin, MD +33472171825 ext +33 jbeuvelot@capio.fr
Contact: Johanne Beuvelot, PhD +33472171825 ext +33 jbeuvelot@capio.fr

Locations
Layout table for location information
France
Clinique de la Sauvegarde Recruiting
Lyon, France, 69009
Contact: Nicolas Bonin, MD    +33472171825 ext +33    jbeuvelot@capio.fr   
Contact: Johanne Beuvelot, PhD    +33472171825 ext +33    jbeuvelot@capio.fr   
Sponsors and Collaborators
Clinique de la Sauvegarde

Layout table for additonal information
Responsible Party: Clinique de la Sauvegarde
ClinicalTrials.gov Identifier: NCT03751618     History of Changes
Other Study ID Numbers: 2017-CSV-001
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clinique de la Sauvegarde:
Hip arthroscopy
capsular suture
Femoral Acetabular Impingement

Additional relevant MeSH terms:
Layout table for MeSH terms
Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes