Shoulder PainCAP-LATARJETNCT05978362
Value of Capsular Repair for Latarjet
A study testing Latarjet technique in people with Shoulder Pain, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The purpose of the study is to evaluate the occurrence of osteoarthritis (YES/NO) by radiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Latarjet technique
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2023to Dec 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male or female, over the age of 18
- Patient with shoulder instability with risk factors for recurrence (ISIS score > 3), requiring surgical stabilization by abutment
- Affiliated patient or beneficiary of a social security scheme
- Patient having been informed and having given his free, informed and written consent.
Who cannot join
- Patient with history of surgery for instability of the same shoulder
- Patient presenting contraindications to the realization of a postoperative scanner
- Patient whose physical and/or psychological health is severely impaired, which according to the investigator may affect the compliance of the study participant
- Patient participating in another clinical research or in a period of exclusion from another research still in progress at the time of inclusion
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant, breastfeeding or parturient woman
- Patient hospitalized without consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Maussins-Nollet
Paris, 75019
Geoffroy NOURISSAT, MD, 768513650 ext. +33, gnourissat@wanadoo.fr
About this study
Official title: Prospective, Multicenter, Randomized Single-blind Study on the Interest of Capsular Repair in the Latarjet Operation
The purpose of the study is to evaluate the occurrence of osteoarthritis (YES/NO) by radiography.
Read the detailed description
This is a prospective, comparative, longitudinal, randomized, single-blind, multicenter study.
This study will validate preliminary results on a technique associating capsular repair with abutment according to Latarjet in the treatment of shoulder instabilities. It may help reduce the risk of osteoarthritis and thus allow patients to maintain a healthy, stable and painless shoulder for longer.
- Conditions
- Shoulder Pain
- Being tested
- Latarjet technique
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latarjet techniqueProcedure or surgery
Realization of a stop according to Latarjet
| Study group | Role | What they receive |
|---|---|---|
| With capsular repair | Experimental | This technique consists of inserting the capsule during the operation according to Latarjet. Receives: Procedure: Latarjet technique |
| Without capsular repair | Active comparator | Latarjet technique without capsular repair Receives: Procedure: Latarjet technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of osteoarthritis
Change from occurrence of osteoarthritis (YES/NO) on X-ray at 5 and 10 years, compared to inclusion X-ray using the Samilson-Prieto classification.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start11 Oct 2023
- Primary completionDec 2037 (estimated)
- Study completionDec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, comparative, longitudinal, randomized single-blind study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978362
- Sponsor's protocol ID
- 2022-A02629-34
- Acronym
- CAP-LATARJET
- Status last verified
- May 2026
- First submitted
- 18 Jul 2023
- Last updated
- 13 May 2026
- 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 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Single-blind Study on the Interest of Capsular Repair in the Latarjet Operation
- ClinicalTrials.gov ID
- NCT05978362
- Acronym / sponsor ID
- CAP-LATARJET / 2022-A02629-34
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- Dec 2037 (estimated)
- Study completion
- Dec 2037 (estimated)
- First posted
- 7 Aug 2023 (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.
The purpose of the study is to evaluate the occurrence of osteoarthritis (YES/NO) by radiography.
Detailed description
This is a prospective, comparative, longitudinal, randomized, single-blind, multicenter study.
This study will validate preliminary results on a technique associating capsular repair with abutment according to Latarjet in the treatment of shoulder instabilities. It may help reduce the risk of osteoarthritis and thus allow patients to maintain a healthy, stable and painless shoulder for longer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, comparative, longitudinal, randomized single-blind study
| Arm | Type | Receives |
|---|---|---|
| With capsular repair | Experimental | Procedure: Latarjet techniqueThis technique consists of inserting the capsule during the operation according to Latarjet. |
| Without capsular repair | Active comparator | Procedure: Latarjet techniqueLatarjet technique without capsular repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient, male or female, over the age of 18
- Patient with shoulder instability with risk factors for recurrence (ISIS score > 3), requiring surgical stabilization by abutment
- Affiliated patient or beneficiary of a social security scheme
- Patient having been informed and having given his free, informed and written consent.
Key exclusion criteria (7 listed)
- Patient with history of surgery for instability of the same shoulder
- Patient presenting contraindications to the realization of a postoperative scanner
- Patient whose physical and/or psychological health is severely impaired, which according to the investigator may affect the compliance of the study participant
- Patient participating in another clinical research or in a period of exclusion from another research still in progress at the time of inclusion
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
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 |
|---|---|---|
| Latarjet techniqueRealization of a stop according to Latarjet | Procedure or surgery | With capsular repair, Without capsular repair |
Primary outcome
occurrence of osteoarthritis
Time frame: 10 years
Change from occurrence of osteoarthritis (YES/NO) on X-ray at 5 and 10 years, compared to inclusion X-ray using the Samilson-Prieto classification.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latarjet technique in people with Shoulder Pain, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geoffroy NOURISSAT, MD (768513650 ext. +33, gnourissat@wanadoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of osteoarthritis (time frame: 10 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 May 2026.