Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial
University of Pittsburgh
Summary
This clinical trial will determine the outcome trajectories of common surgeries (arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, Latarjet) with post-operative rehabilitation and identification of prognostic factors among patients with acute or recurrent anterior shoulder instability with subcritical bone loss. The results of the study assist in optimizing time to return to military duty, work and sports, and patient-reported physical function for military personnel and civilians with traumatic anterior shoulder instability and 10-20% glenoid bone loss. This study will provide a critical clinical advancement of a previously unaddressed and common clinical scenario.
Description
The objective of this study is to determine the outcome trajectories of common surgeries (arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, Latarjet) with post-operative rehabilitation and identification of prognostic factors among military personnel and civilians with acute or recurrent anterior shoulder instability with subcritical bone loss. Aim 1: The investigators will determine the acute and long term patient relevant outcomes (Western Ontario Shoulder Instability score \[WOSI\], time to RTD/A at pre-injury levels, and recurrent instability/re-injury) at…
Eligibility
- Age range
- 17–50 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Civilians and military personnel ages 17 to 50 * Traumatic anterior shoulder dislocation * Associated subcritical bone loss between 10-20% less the glenoid width quantified by standard of care CT scan, MRI, or 3D-MRI scan * Had shoulder instability surgery using either 1) arthroscopic Bankart repair with remplissage of Hill-Sachs lesion; 2) open Bankart; or 3) Latarjet Exclusion Criteria: * Chronic, non-traumatic multi-directional instability based on clinical exam * Concurrent shoulder injury in the involved shoulder (e.g., rotator cuff tears, motor nerve pathologies,…
Interventions
- ProcedureArthroscopic Bankart repair procedure
Bankart repair with remplissage consists of arthroscopic anterior inferior capsulolabral repair with arthroscopic infraspinatus tenodesis to the posterior humeral head.
- ProcedureOpen Bankart
Open Bankart repair consists of anterior capsulorrhaphy with labral repair.
- ProcedureLatarjet
Latarjet consists of open transfer of the coracoid to the anterior glenoid bone deficiency.
- OtherPost-Operative Rehabilitation
Post-operative rehabilitation will be conducted following surgical procedure-specific rehabilitation guidelines and will be progressed based on individual needs.
Locations (15)
- Mayo ClinicTempe, Arizona
- Naval Medical CenterSan Diego, California
- Steadman ClinicVail, Colorado
- University of Connecticut Health CenterFarmington, Connecticut
- US Naval Health Clinic (Academy)Annapolis, Maryland
- Walter Reed National Military Medical CenterBethesda, Maryland