Evaluation of Non Inferiority of Non Capsular Suture in Femoroacetabular Impingement Arthroscopic Treatment (SUTURCAP)
Primary Purpose
Femoral Acetabular Impingement
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hip arthroscopy
Sponsored by
About this trial
This is an interventional other trial for Femoral Acetabular Impingement focused on measuring Hip arthroscopy, capsular suture, Femoral Acetabular Impingement
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
Sites / Locations
- Clinique de la Sauvegarde
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Capsular suture
No capsular suture
Arm Description
Capsular suture at the end of hip arthroscopy
No capsular suture at the end of hip arthroscopy
Outcomes
Primary Outcome Measures
patient reported outcomes (questionnaires)
HAGOS score
Secondary Outcome Measures
patient reported outcomes (questionnaires)
modified Harris Hip Score
patient reported outcomes (questionnaires)
iHOT-12
Full Information
NCT ID
NCT03751618
First Posted
July 3, 2018
Last Updated
September 12, 2023
Sponsor
Clinique de la Sauvegarde
1. Study Identification
Unique Protocol Identification Number
NCT03751618
Brief Title
Evaluation of Non Inferiority of Non Capsular Suture in Femoroacetabular Impingement Arthroscopic Treatment
Acronym
SUTURCAP
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 7, 2018 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique de la Sauvegarde
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Acetabular Impingement
Keywords
Hip arthroscopy, capsular suture, Femoral Acetabular Impingement
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, monocentric, randomized, double blind study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capsular suture
Arm Type
Experimental
Arm Description
Capsular suture at the end of hip arthroscopy
Arm Title
No capsular suture
Arm Type
Active Comparator
Arm Description
No capsular suture at the end of hip arthroscopy
Intervention Type
Procedure
Intervention Name(s)
Hip arthroscopy
Intervention Description
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 Measure Information:
Title
patient reported outcomes (questionnaires)
Description
HAGOS score
Time Frame
2 years
Secondary Outcome Measure Information:
Title
patient reported outcomes (questionnaires)
Description
modified Harris Hip Score
Time Frame
6 months
Title
patient reported outcomes (questionnaires)
Description
iHOT-12
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Clinique de la Sauvegarde
City
Lyon
ZIP/Postal Code
69009
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Non Inferiority of Non Capsular Suture in Femoroacetabular Impingement Arthroscopic Treatment
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