Trials / Recruiting
RecruitingNCT03453710
Remplissage Versus Latarjet Coracoid Transfer for Recurrent Shoulder Instability
Arthroscopic Bankart Repair and Remplissage Versus Latarjet Coracoid Transfer for Recurrent Anterior Glenohumeral Instability With Subcritical Bone Loss - A Randomized Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Western University, Canada · Academic / Other
- Sex
- All
- Age
- 15 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
This is a pilot study designed as a prospective, randomized controlled trial comparing arthroscopic Bankart repair and Remplissage with an open Latarjet coracoid transfer for the treatment of recurrent anterior glenohumeral instability with subcritical bone loss.
Detailed description
Presently, consensus guidelines for the surgical management of anterior glenohumeral instability are lacking. While there has been continual evolution in available arthroscopic instrumentation, this has not translated to improvements in patient outcomes. Isolated arthroscopic bankart repair is often associated with unacceptably high rates of failure, with a recent systematic review identifying continued recurrence rates of 14.2%. Improved recognition of bone defects and identification of critical defect sizes that contribute to recurrent instability and failed stabilization have lead to improvements in treatment algorithms. It has been widely accepted that glenoid defects exceeding 20% of anteroposterior (AP) width and humeral head defects exceeding 30% of the humeral head width contribute to recurrent instability. For defects of this magnitude, isolated arthroscopic Bankart repair is insufficient in restoring joint stability, and more extensive procedures are required. This can include adding a remplissage to the arthroscopic Bankart repair or open allograft reconstruction for humeral defects; or Latarjet coracoid transfer for glenoid defects. However, often patients present with combined 'bipolar' bone loss, where individual defects are subcritical in size. There is increasing recognition that the presence of this combined bone loss may lead to increased rates of failure with an isolated arthroscopic bankart repair. Currently, accepted treatment options for bipolar bone loss include a combined arthroscopic Bankart repair and remplissage, or a Latarjet coracoid transfer. While there is supportive biomechanical data for each procedure, and limited case series in the literature, there remains a paucity of high-quality evidence to guide treatment for this complex clinical scenario. Consequently, we aim to perform a pilot study designed as a prospective, randomized controlled trial comparing arthroscopic Bankart repair and Remplissage with an open Latarjet coracoid transfer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Bankart Repair plus Remplissage | Arthroscopic Bankart repair with a minimum of 3 anchors 1 or 2 anchor Remplissage subsequently performed with percutaneous anchor insertion in the base of the Hill-Sachs defect, and sutures passed in a horizontal mattress configuration 1 cm apart, tied in the subacromial space. |
| PROCEDURE | Latarjet coracoid transfer | Coracoid transfer performed via deltopectoral approach with horizontal subscapularis split. Graft placed in the conventional orientation, secured with 2 screws, ensuring the graft is not lateral to the glenoid rim. |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2018-03-05
- Last updated
- 2024-04-30
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT03453710. Inclusion in this directory is not an endorsement.