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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03751618
Acronym
SUTURCAP
Enrollment
90
Registered
2018-11-23
Start date
2018-02-07
Completion date
2023-06-01
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Acetabular Impingement

Keywords

Hip arthroscopy, capsular suture, Femoral Acetabular Impingement

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

Interventions

PROCEDUREHip 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.

Sponsors

Clinique de la Sauvegarde
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Intervention model description

Prospective, monocentric, randomized, double blind study

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
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

Design outcomes

Primary

MeasureTime frameDescription
patient reported outcomes (questionnaires)2 yearsHAGOS score

Secondary

MeasureTime frameDescription
patient reported outcomes (questionnaires)6 monthsmodified Harris Hip Score

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026