RecruitingNCT04809064

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


Sponsor

University of Pittsburgh

Enrollment

450 participants

Start Date

Jan 24, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 17 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Arthroscopic Bankart repair procedure, a procedure called Latarjet, and others for people with anterior shoulder dislocation, glenohumeral dislocation, and other related conditions. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 17 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Clinic

Tempe, Arizona, United States

Naval Medical Center

San Diego, California, United States

Steadman Clinic

Vail, Colorado, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

US Naval Health Clinic (Academy)

Annapolis, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

Naval Medical Center Camp Lejeune

Marine Corps Base Camp Lejeune, North Carolina, United States

Wake Forest University

Winston-Salem, North Carolina, United States

Ohio State University, Wexner Medical Center

Columbus, Ohio, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital - Brown University Health

Providence, Rhode Island, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

San Antonio Military Medical Center

Fort Sam Houston, Texas, United States

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NCT04809064


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