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

Part of paid clinical trials in Tempe, Arizona.

Sponsor: University of Pittsburgh
Study ID: NCT04809064
Status: Recruiting

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Conditions

Anterior Shoulder Dislocation
Glenohumeral Dislocation
Shoulder Dislocation

Eligibility Criteria

Sex: ALL
Age: 17 Years - 50 Years
Healthy Volunteers: Not accepted

Interventions

Arthroscopic Bankart repair procedure — PROCEDURE
Bankart repair with remplissage consists of arthroscopic anterior inferior capsulolabral repair with arthroscopic infraspinatus tenodesis to the posterior humeral head.
Open Bankart — PROCEDURE
Open Bankart repair consists of anterior capsulorrhaphy with labral repair.
Latarjet — PROCEDURE
Latarjet consists of open transfer of the coracoid to the anterior glenoid bone deficiency.
Post-Operative Rehabilitation — OTHER
Post-operative rehabilitation will be conducted following surgical procedure-specific rehabilitation guidelines and will be progressed based on individual needs.

Study Details

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 Dates

Start date: Jan 24, 2022
Status verified: May 2026
Primary completion: Sep 30, 2027
Completion: Sep 30, 2027

Study Design

Enrollment: 450 participants (estimated)

Arms

Arm: Arthroscopic Bankart repair with remplissage of Hill-Sachs lesion/rehabilitation
Arthroscopic Bankart repair surgery with remplissage of Hill-Sachs lesion and post-operative rehabilitation.
Arm: Open Bankart/rehabilitation
Open Bankart surgery and post-operative rehabilitation.
Arm: Latarjet/rehabilitation
Latarjet surgical procedure and post-operative rehabilitation.

Primary Outcome Measure

Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 3 months after surgery ]

Central Contacts

Adam Popchak, PhD, PT
(412) 383-6627
[email protected]
Jonathan Dickens, MD

Locations (15)

Facility	City	State	ZIP	Site coordinators
Mayo Clinic	Tempe	Arizona	85288	John Tokish, MD [email protected] John Tokish, MD (PRINCIPAL_INVESTIGATOR)
Naval Medical Center	San Diego	California	92134	-
Steadman Clinic	Vail	Colorado	81657	-
University of Connecticut Health Center	Farmington	Connecticut	06030	-
US Naval Health Clinic (Academy)	Annapolis	Maryland	21402	Robert Waltz, MC, USN [email protected] Robert Waltz, MC, USN (PRINCIPAL_INVESTIGATOR)
Walter Reed National Military Medical Center	Bethesda	Maryland	20089	-
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	27517	Alex Creighton, MD [email protected] Alex Creighton, MD (PRINCIPAL_INVESTIGATOR)
Duke University	Durham	North Carolina	27705	Jonathan Dickens, MD [email protected] Jonathan Dickens, MD (SUB_INVESTIGATOR) Brian Lau, MD (PRINCIPAL_INVESTIGATOR)
Naval Medical Center Camp Lejeune	Marine Corps Base Camp Lejeune	North Carolina	28547	-
Wake Forest University	Winston-Salem	North Carolina	27157	Brian Waterman, MD [email protected] Brian Waterman, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University, Wexner Medical Center	Columbus	Ohio	43202	Julie Bishop, MD [email protected] Julie Bishop, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh	Pittsburgh	Pennsylvania	15203	Albert Lin, MD [email protected] Albert Lin, MD (PRINCIPAL_INVESTIGATOR)
Rhode Island Hospital - Brown University Health	Providence	Rhode Island	02903	Stephen Marcaccio, MD [email protected] Stephen Marcaccio, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical Center	Nashville	Tennessee	37232	Lance LeClere, MD [email protected] Lance LeClere, MD (PRINCIPAL_INVESTIGATOR)
San Antonio Military Medical Center	Fort Sam Houston	Texas	78234	Daniel J Cognetti, MD [email protected] Daniel J Cognetti, MD (PRINCIPAL_INVESTIGATOR)

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By research site

Mayo Clinic· Tempe, AZ Naval Medical Center· San Diego, CA Steadman Clinic· Vail, CO University of Connecticut Health Center· Farmington, CT US Naval Health Clinic (Academy)· Annapolis, MD Walter Reed National Military Medical Center· Bethesda, MD

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