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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Procedure, Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 17
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Mayo Clinic
RECRUITING
Tempe
California
Naval Medical Center
RECRUITING
San Diego
Colorado
Steadman Clinic
RECRUITING
Vail
Connecticut
University of Connecticut Health Center
RECRUITING
Farmington
Maryland
US Naval Health Clinic (Academy)
RECRUITING
Annapolis
Walter Reed National Military Medical Center
RECRUITING
Bethesda
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Duke University
RECRUITING
Durham
Naval Medical Center Camp Lejeune
RECRUITING
Marine Corps Base Camp Lejeune
Wake Forest University
RECRUITING
Winston-salem
Ohio
Ohio State University, Wexner Medical Center
RECRUITING
Columbus
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Rhode Island
Rhode Island Hospital - Brown University Health
RECRUITING
Providence
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
San Antonio Military Medical Center
RECRUITING
Fort Sam Houston
Contact Information
Primary
Adam Popchak, PhD, PT
ajp64@pitt.edu
(412) 383-6627
Backup
Jonathan Dickens, MD
Time Frame
Start Date: 2022-01-24
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 450
Treatments
Arthroscopic Bankart repair with remplissage of Hill-Sachs lesion/rehabilitation
Arthroscopic Bankart repair surgery with remplissage of Hill-Sachs lesion and post-operative rehabilitation.
Open Bankart/rehabilitation
Open Bankart surgery and post-operative rehabilitation.
Latarjet/rehabilitation
Latarjet surgical procedure and post-operative rehabilitation.
Related Therapeutic Areas
Sponsors
Leads: University of Pittsburgh
Collaborators: Duke University

This content was sourced from clinicaltrials.gov