Shoulder Anterior Latarjet InstabilityNCT07520669
Does Capsuloplasty Reduce External Rotation After Coracoid Impingement?
A study testing Open coracoid impingement repair without capsuloplasty and Open coracoid impingement repair with capsuloplasty in people with Shoulder Anterior Latarjet Instability, run by Clinique du Sport, Bordeaux Mérignac at 1 site in France.
Trial summary
The coracoid anchor (Latarjet procedure) is the gold standard technique for treating recurrent anterior shoulder instability. Despite excellent postoperative stability, a reduction in external rotation has been reported, which can affect function, glenohumeral kinematics, and return to sports, particularly among… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Shoulder Anterior Latarjet Instability
- What is being tested?
- Open coracoid impingement repair without capsuloplasty and Open coracoid impingement repair with capsuloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2026to 31 Dec 2028
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Standard indications for surgery (glenoid bone loss, advanced Hill-Sachs lesion, failed Bankart repair, contact sports, etc.).
- Shoulder not previously operated on
Who cannot join
- Significant associated rotator cuff pathology, associated SLAP lesion
- Advanced glenohumeral osteoarthritis.
- Recurrent impingement, history of shoulder surgery
- Presence of severe external rotation deficit of the shoulder prior to surgery
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 du Sport
Mérignac, 33700
Marion Mandon, PhD, +33 6 78 27 76 72, mmandon@vivalto-sante.com
Florent Baldairon, MD
About this study
Official title: Does Capsuloplasty Reduce External Rotation After Coracoid Impingement? A Randomized Controlled Trial
The coracoid anchor (Latarjet procedure) is the gold standard technique for treating recurrent anterior shoulder instability. Despite excellent postoperative stability, a reduction in external rotation has been reported, which can affect function, glenohumeral kinematics, and return to sports, particularly among athletes in combat and contact sports.
The combination of an anterior capsuloplasty with the coracoid buttress is performed inconsistently among surgeons, with no consensus; the capsular repair techniques associated with the Latarjet procedure vary widely among teams. Some teams routinely perform capsular repair to enhance stability and reposition the capsule on the glenoid rim, while others consider it non-essential and potentially responsible for further limiting external rotation.
Read more
To date, there are few studies specifically evaluating the impact of capsuloplasty on joint range of motion beyond the end-stop, and the available results remain contradictory. In 2023, the team of Kim et al. suggested that the Latarjet technique without capsular repair resulted in good restoration of laxity and good clinical outcomes, with less early postoperative limitation of external rotation than that observed with the same technique combined with capsular repair. Nevertheless, at 1 year, there was no significant deficit in external rotation between the two groups.
A prospective randomized comparative analysis will determine whether the addition of capsuloplasty significantly alters ranges of motion, given identical surgical and rehabilitation protocols. The results could clarify the indications for this procedure, optimize surgical practices, and improve recommendations for the management of shoulder instability.
- Conditions
- Shoulder Anterior Latarjet Instability
- Being tested
- Open coracoid impingement repair without capsuloplasty, Open coracoid impingement repair with capsuloplasty
- Keywords
- instability, dislocation, Latarjet
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open coracoid impingement repair without capsuloplastyProcedure or surgery
All patients undergo an open coracoid osteotomy performed using the center's standard technique. The procedure is performed under general anesthesia combined with an interscalene block. The patient is positioned in a semi-sitting position.
The approach is delto-pectoral; an osteotomy of the coracoid process is performed after detachment of the acromiocoracoid ligament and the pectoralis minor tendon. A tunnel is created through the subscapularis muscle, followed by a horizontal capsulotomy with placement of guide sutures on both capsular margins. The glenoid is re-contoured, and the stop is then fixed to the glenoid with two screws (Asnis-Stryker, 3.5 mm in diameter).
Open coracoid impingement repair with capsuloplastyProcedure or surgery
All patients undergo an open coracoid osteotomy performed using the center's standard technique. The procedure is performed under general anesthesia combined with an interscalene block. The patient is positioned in a semi-sitting position.
The approach is delto-pectoral; an osteotomy of the coracoid process is performed after detachment of the acromiocoracoid ligament and the pectoralis minor tendon. A tunnel is created through the subscapularis muscle, followed by a horizontal capsulotomy with placement of guide sutures on both capsular margins. The glenoid is re-contoured, and the stop is then fixed to the glenoid with two screws (Asnis-Stryker, 3.5 mm in diameter).
Anterior capsuloplasty is performed using a predefined, reproducible technique: horizontal, with an anchor.
| Study group | Role | What they receive |
|---|---|---|
| Open coracoid impingement repair without capsuloplasty | Active comparator | Not described Receives: Procedure: Open coracoid impingement repair without capsuloplasty |
| Open coracoid impingement repair with standardized anterior capsuloplasty | Experimental | Not described Receives: Procedure: Open coracoid impingement repair with capsuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of external rotation
arm against the body and in 90° abduction : measure of range of external rotation
Measured: 12 months after surgery
Secondary outcomes (2)
Recurrence of instability
Measured: 12 months after surgery
Rowe score
Score with 4 parts :
- mobility (10 points)
- function (50 points)
- pain (10 points)
- stability (30 points) Each part is scored with a Likert scale (3 or 4 points). Total scoring is / 100 points.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start2 Jul 2026
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Anterior Latarjet InstabilityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique du Sport, Bordeaux Mérignac
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent Baldairon, MD, Principal investigator, Clinique du sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520669
- Sponsor's protocol ID
- 2025-65-SBM
- Status last verified
- Jul 2026
- First submitted
- 3 Apr 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Capsuloplasty Reduce External Rotation After Coracoid Impingement? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07520669
- Acronym / sponsor ID
- 2025-65-SBM
- Conditions
- Shoulder Anterior Latarjet Instability
- Keywords
- instability, dislocation, Latarjet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Clinique du Sport, Bordeaux MérignacUniversity, hospital or other
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Apr 2026 (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 coracoid anchor (Latarjet procedure) is the gold standard technique for treating recurrent anterior shoulder instability. Despite excellent postoperative stability, a reduction in external rotation has been reported, which can affect function, glenohumeral kinematics, and return to sports, particularly among athletes in combat and contact sports.
The combination of an anterior capsuloplasty with the coracoid buttress is performed inconsistently among surgeons, with no consensus; the capsular repair techniques associated with the Latarjet procedure vary widely among teams. Some teams routinely perform capsular repair to enhance stability and reposition the capsule on the glenoid rim, while others consider it non-essential and potentially responsible for further limiting external rotation.
To date, there are few studies specifically evaluating the impact of capsuloplasty on joint range of motion beyond the end-stop, and the available results remain contradictory. In 2023, the team of Kim et al. suggested that the Latarjet technique without capsular repair resulted in good restoration of laxity and good clinical outcomes, with less early postoperative limitation of external rotation than that observed with the same technique combined with capsular repair. Nevertheless, at 1 year, there was no significant deficit in external rotation between the two groups.
A prospective randomized comparative analysis will determine whether the addition of capsuloplasty significantly alters ranges of motion, given identical surgical and rehabilitation protocols. The results could clarify the indications for this procedure, optimize surgical practices, and improve recommendations for the management of shoulder instability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open coracoid impingement repair without capsuloplasty | Active comparator | Procedure: Open coracoid impingement repair without capsuloplasty |
| Open coracoid impingement repair with standardized anterior capsuloplasty | Experimental | Procedure: Open coracoid impingement repair with capsuloplasty |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Standard indications for surgery (glenoid bone loss, advanced Hill-Sachs lesion, failed Bankart repair, contact sports, etc.).
- Shoulder not previously operated on
Key exclusion criteria (4 listed)
- Significant associated rotator cuff pathology, associated SLAP lesion
- Advanced glenohumeral osteoarthritis.
- Recurrent impingement, history of shoulder surgery
- Presence of severe external rotation deficit of the shoulder prior to surgery
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 |
|---|---|---|
| Open coracoid impingement repair without capsuloplastyAll patients undergo an open coracoid osteotomy performed using the center's standard technique. The procedure is performed under general anesthesia combined with an interscalene block. The patient is positioned in a semi-sitting position. The approach is delto-pectoral; an osteotomy of the coracoid process is performed after detachment of the acromiocoracoid ligament and the pectoralis minor tendon. A tunnel is created through the subscapularis muscle, followed by a horizontal capsulotomy with placement of guide sutures on both capsular margins. The glenoid is re-contoured, and the stop is then fixed to the glenoid with two screws (Asnis-Stryker, 3.5 mm in diameter). | Procedure or surgery | Open coracoid impingement repair without capsuloplasty |
| Open coracoid impingement repair with capsuloplastyAll patients undergo an open coracoid osteotomy performed using the center's standard technique. The procedure is performed under general anesthesia combined with an interscalene block. The patient is positioned in a semi-sitting position. The approach is delto-pectoral; an osteotomy of the coracoid process is performed after detachment of the acromiocoracoid ligament and the pectoralis minor tendon. A tunnel is created through the subscapularis muscle, followed by a horizontal capsulotomy with placement of guide sutures on both capsular margins. The glenoid is re-contoured, and the stop is then fixed to the glenoid with two screws (Asnis-Stryker, 3.5 mm in diameter). Anterior capsuloplasty is performed using a predefined, reproducible technique: horizontal, with an anchor. | Procedure or surgery | Open coracoid impingement repair with standardized anterior capsuloplasty |
Primary outcome
Range of external rotation
Time frame: 12 months after surgery
arm against the body and in 90° abduction : measure of range of external rotation
2 secondary outcomes
Recurrence of instability
Time frame: 12 months after surgery
Rowe score
Time frame: 12 months after surgery
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 10 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Shoulder Anterior Latarjet Instability
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Surgical Stabilization of Anterior Shoulder Instability Using the Open Latarjet Procedure, With or Without Anterior Capsuloplasty Using the Coracoacromial Ligament.
Recurrent Anterior Shoulder Instability
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Remplissage Versus Latarjet Coracoid Transfer for Recurrent Shoulder Instability
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Shoulder Instability Surgery: Latarjet Technique With Surgical Tape Versus Screw Fixation
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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.
Florent Baldairon, MD principal investigator
Clinique du sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open coracoid impingement repair without capsuloplasty and Open coracoid impingement repair with capsuloplasty in people with Shoulder Anterior Latarjet Instability, run by Clinique du Sport, Bordeaux Mérignac 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 2 inclusion and 4 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 10 Jul 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 Marion Mandon, PhD (+33 6 78 27 76 72, mmandon@vivalto-sante.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of external rotation (time frame: 12 months after surgery). 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 10 Jul 2026.