Evaluation of Non Inferiority of Non Capsular Suture in Femoroacetabular Impingement Arthroscopic Treatment
NCT ID: NCT03751618
Last Updated: 2023-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2018-02-07
2023-06-01
Brief Summary
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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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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Capsular suture
Capsular suture at the end of hip arthroscopy
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.
No capsular suture
No capsular suture at the end of hip arthroscopy
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
99 Years
ALL
No
Sponsors
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Clinique de la Sauvegarde
OTHER
Responsible Party
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Locations
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Clinique de la Sauvegarde
Lyon, , France
Countries
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Other Identifiers
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2017-CSV-001
Identifier Type: -
Identifier Source: org_study_id
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