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

Recruiting now

Conditions studied: Shoulder Dislocation, Glenohumeral Dislocation, Anterior Shoulder Dislocation

In brief

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.

Key facts

Study ID

NCT04809064

Run by

University of Pittsburgh

People needed

450

Starts

2022-01-24

Expected to finish

2027-09-30

Last updated by the study team

2026-06-08

Who can join

Age: 17 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Humeral sided bone lesions (Hill-Sachs lesion) that is sufficiently large enough to render the lesion "off-track" even after a bony augmentation procedure would be performed
• Neuromuscular, neurological and other movement control pathologies including seizures
• Vascular injury associated with the shoulder trauma that compromise adequate/normal healing or interferes with usual course of care
• Traumatic brain injury or any condition that would preclude the ability to comply with post-operative guidelines
• Cartilage lesion finding in the involved shoulder that would interfere with usual course of care
• Known pregnancy at time of imagining and/or surgery based upon standard of care testing procedures
• Any issue with the contralateral shoulder that would preclude participation in research procedures
• Any condition in the opinion of the investigator/clinician that would preclude or limit full participation in study activities
• Absence of a fixed address or no means of contact
• Known inability to be available at all follow-up time points
• Does not plan to return to pre-injury levels of work, sports or military duty

Where it is running

• San Antonio Military Medical Center — Fort Sam Houston, Texas, United States (enrolling)
• Ohio State University, Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• Rhode Island Hospital - Brown University Health — Providence, Rhode Island, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Mayo Clinic — Tempe, Arizona, United States (enrolling)
• US Naval Health Clinic (Academy) — Annapolis, Maryland, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Wake Forest University — Winston-Salem, North Carolina, United States (enrolling)
• Naval Medical Center — San Diego, California, United States
• Steadman Clinic — Vail, Colorado, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Naval Medical Center Camp Lejeune — Marine Corps Base Camp Lejeune, North Carolina, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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