NCT07520669

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
29mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Dec 2028

First Submitted

Initial submission to the registry

April 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

July 2, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

2.3 years

First QC Date

April 3, 2026

Last Update Submit

July 8, 2026

Conditions

Keywords

instabilitydislocationLatarjet

Outcome Measures

Primary Outcomes (1)

  • Range of external rotation

    arm against the body and in 90° abduction : measure of range of external rotation

    12 months after surgery

Secondary Outcomes (2)

  • Recurrence of instability

    12 months after surgery

  • Rowe score

    12 months after surgery

Study Arms (2)

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

Interventions

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.

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).

Open coracoid impingement repair without capsuloplasty

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Standard indications for surgery (glenoid bone loss, advanced Hill-Sachs lesion, failed Bankart repair, contact sports, etc.).
  • Shoulder not previously operated on

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique du Sport

Mérignac, 33700, France

RECRUITING

MeSH Terms

Conditions

Joint Dislocations

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesWounds and Injuries

Study Officials

  • Florent Baldairon, MD

    Clinique du sport

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2026

First Posted

April 9, 2026

Study Start

July 2, 2026

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations