Health Trials

Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial

ConditionsShoulder DislocationGlenohumeral DislocationAnterior Shoulder Dislocation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age17-50
SponsorUniversity of Pittsburgh

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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, osteoarthritis of a Samilson-Prieto grade >2)

Have a history of shoulder surgery in the involved shoulder (prior instability surgery that included any of the following and the planned procedure would be a repeat of the index procedure: 1) arthroscopic Bankart repair with a remplissage of Hill-Sachs lesion, 2) open Bankart, or 3) Latarjet [previous isolated arthroscopic Bankart repair only would not be an exclusion criterion], rotator cuff repair, intra-articular soft tissue surgery); rotator cuff repair, intra-articular soft tissue surgery)

Prior rotator cuff procedure on involved shoulder (including intra-articular soft tissue surgery

Trial design

Treatments tested in this trial

  • Arthroscopic Bankart repair procedure
  • Open Bankart
  • Latarjet
  • Post-Operative Rehabilitation

Treatment groups

450 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Pittsburgh

Lead sponsor

Duke University

Collaborator

Source ClinicalTrials.gov