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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Clinique de la Sauvegarde
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- patient reported outcomes (questionnaires)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
patient reported outcomes (questionnaires)
Time Frame: 2 years
HAGOS score
Secondary Outcomes
- patient reported outcomes (questionnaires)(1 year)