Femoral Acetabular ImpingementSUTURCAPNCT03751618
Evaluation of Non Inferiority of Non Capsular Suture in Femoroacetabular Impingement Arthroscopic Treatment
A study testing Hip arthroscopy in people with Femoral Acetabular Impingement, run by Clinique de la Sauvegarde at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Femoral Acetabular Impingement
- What is being tested?
- Hip arthroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2018to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Femoral Acetabular Impingement
- Being tested
- Hip arthroscopy
- Keywords
- Hip arthroscopy, capsular suture, Femoral Acetabular Impingement
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip arthroscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Capsular suture | Experimental | Capsular suture at the end of hip arthroscopy Receives: Procedure: Hip arthroscopy |
| No capsular suture | Active comparator | No capsular suture at the end of hip arthroscopy Receives: Procedure: Hip arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient reported outcomes (questionnaires)
HAGOS score
Measured: 2 years
Secondary outcomes (2)
patient reported outcomes (questionnaires)
modified Harris Hip Score
Measured: 6 months
patient reported outcomes (questionnaires)
iHOT-12
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start7 Feb 2018
- Primary completion1 Mar 2021
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Acetabular ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, monocentric, randomized, double blind study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique de la Sauvegarde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751618
- Sponsor's protocol ID
- 2017-CSV-001
- Acronym
- SUTURCAP
- Status last verified
- Nov 2018
- First submitted
- 3 Jul 2018
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03751618
- Acronym / sponsor ID
- SUTURCAP / 2017-CSV-001
- Conditions
- Femoral Acetabular Impingement
- Keywords
- Hip arthroscopy, capsular suture, Femoral Acetabular Impingement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Clinique de la SauvegardeUniversity, hospital or other
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, monocentric, randomized, double blind study
| Arm | Type | Receives |
|---|---|---|
| Capsular suture | Experimental | Procedure: Hip arthroscopyCapsular suture at the end of hip arthroscopy |
| No capsular suture | Active comparator | Procedure: Hip arthroscopyNo capsular suture at the end of hip arthroscopy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip arthroscopySuture 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. | Procedure or surgery | Capsular suture, No capsular suture |
Primary outcome
patient reported outcomes (questionnaires)
Time frame: 2 years
HAGOS score
2 secondary outcomes
patient reported outcomes (questionnaires)
Time frame: 6 months
patient reported outcomes (questionnaires)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip arthroscopy in people with Femoral Acetabular Impingement, run by Clinique de la Sauvegarde at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient reported outcomes (questionnaires) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.