Does Capsuloplasty Reduce External Rotation After Coracoid Impingement?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorClinique du Sport, Bordeaux Mérignac
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Standard indications for surgery (glenoid bone loss, advanced Hill-Sachs lesion, failed Bankart repair, contact sports, etc.).
Shoulder not previously operated on
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Open coracoid impingement repair without capsuloplasty
Procedure/SurgeryAll 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 capsuloplasty
Procedure/SurgeryAll 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.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Open coracoid impingement repair without capsuloplastyActive comparator 1 intervention
Group B: Open coracoid impingement repair with standardized anterior capsuloplastyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Range of external rotation
arm against the body and in 90° abduction : measure of range of external rotation
Time frame
12 months after surgerySecondary outcomes
1
Recurrence of instability
Time frame
12 months after surgery2
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.
Time frame
12 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov