- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520669
Does Capsuloplasty Reduce External Rotation After Coracoid Impingement?
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.
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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marion Mandon, PhD
- Phone Number: +33 6 78 27 76 72
- Email: mmandon@vivalto-sante.com
Study Locations
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-
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Mérignac, France, 33700
- Clinique du Sport
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Contact:
- Marion Mandon, PhD
- Phone Number: +33 6 78 27 76 72
- Email: mmandon@vivalto-sante.com
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Principal Investigator:
- Florent Baldairon, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Standard indications for surgery (glenoid bone loss, advanced Hill-Sachs lesion, failed Bankart repair, contact sports, etc.).
- Shoulder not previously operated on
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Open coracoid impingement repair without capsuloplasty
|
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). |
|
Experimental: Open coracoid impingement repair with standardized anterior capsuloplasty
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of external rotation
Time Frame: 12 months after surgery
|
arm against the body and in 90° abduction : measure of range of external rotation
|
12 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recurrence of instability
Time Frame: 12 months after surgery
|
12 months after surgery
|
|
|
Rowe score
Time Frame: 12 months after surgery
|
Score with 4 parts :
|
12 months after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Florent Baldairon, MD, Clinique du Sport
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-65-SBM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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