Actively Recruiting
Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial
Led by University of Pittsburgh · Updated on 2026-06-08
450
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
D
Duke University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the outcomes of common surgeries for patients with acute or recurrent anterior shoulder instability who have subcritical bone loss of 10-20%. The study focuses on military personnel and civilians aged 17 to 50 who have experienced traumatic anterior shoulder dislocation. The goal is to understand how different surgical options affect recovery, return to work, sports, and physical function over time. The study compares three surgical procedures: arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart repair, and the Latarjet procedure. All participants will receive post-operative rehabilitation tailored to their surgery. The choice of surgery is made jointly by the patient and surgeon. Participants will be followed for 24 months to track outcomes. Participants will undergo imaging scans such as CT or 3D-MRI to measure bone loss and confirm eligibility. Researchers will collect data at multiple time points up to two years after surgery, including patient-reported physical function scores, time to return to pre-injury activities, and any recurrent instability or re-injury events. Additional assessments include range of motion, muscle strength, functional tests, pain, medication use, and quality of life measures. This extensive monitoring aims to identify factors that influence recovery and long-term success.
CONDITIONS
Brief Title
Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Civilians and military personnel ages 17 to 50
- Traumatic anterior shoulder dislocation
- Subcritical bone loss of 10-20% of the glenoid width confirmed by CT, MRI, or 3D-MRI scan
- Had shoulder instability surgery using one of the following: arthroscopic Bankart repair with remplissage of Hill-Sachs lesion, open Bankart, or Latarjet
- Plans to return to physically demanding work, sports, or military duty
You will not qualify if you...
- Chronic, non-traumatic multi-directional shoulder instability
- Other shoulder injuries such as rotator cuff tears, motor nerve problems, or osteoarthritis above Samilson-Prieto grade 2
- History of prior shoulder surgery in the involved shoulder related to instability or soft tissue repair except isolated arthroscopic Bankart repair
- Large humeral bone lesions that are off-track despite augmentation
- Neuromuscular or neurological conditions including seizures
- Vascular injury related to shoulder trauma that affects healing
- Traumatic brain injury or conditions preventing compliance with post-operative care
- Cartilage lesions interfering with usual care
- Known pregnancy at time of imaging or surgery
- Issues with the opposite shoulder preventing participation
- Any condition limiting full study participation as judged by the investigator
- No fixed address or means of contact
- Inability to attend all follow-up visits
- No plan to return to pre-injury levels of work, sports, or military duty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for imaging to quantify bone loss
Duration - Surgery day plus initial recovery period
Participants undergo one of three surgical stabilization procedures to treat shoulder instability followed by immediate post-operative care.
1 surgical procedure visit and several follow-up visits in the first 6 weeks
Duration - Up to 24 months
Participants follow a post-operative rehabilitation program tailored to their surgical procedure, focusing on restoring range of motion, strength, and functional performance.
Regular rehabilitation visits and assessments over 24 months
Duration - Up to 24 months
Participants are monitored over 24 months to assess recovery outcomes, including physical function, return to activity, and recurrent shoulder instability.
Monthly assessments starting 3 months after surgery continuing to 24 months
Trial Site Locations
Total: 15 locations
1
Mayo Clinic
Tempe, Arizona, United States, 85288
Actively Recruiting
2
Naval Medical Center
San Diego, California, United States, 92134
Active, Not Recruiting
3
Steadman Clinic
Vail, Colorado, United States, 81657
Active, Not Recruiting
4
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Active, Not Recruiting
5
US Naval Health Clinic (Academy)
Annapolis, Maryland, United States, 21402
Actively Recruiting
6
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20089
Active, Not Recruiting
7
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27517
Actively Recruiting
8
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
9
Naval Medical Center Camp Lejeune
Marine Corps Base Camp Lejeune, North Carolina, United States, 28547
Active, Not Recruiting
10
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
11
Ohio State University, Wexner Medical Center
Columbus, Ohio, United States, 43202
Actively Recruiting
12
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15203
Actively Recruiting
13
Rhode Island Hospital - Brown University Health
Providence, Rhode Island, United States, 02903
Actively Recruiting
14
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
15
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States, 78234
Actively Recruiting
Research Team
A
Adam Popchak, PhD, PT
J
Jonathan Dickens, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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