Actively Recruiting

Age: 17Years - 50Years
All Genders
NCT04809064

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

Led by University of Pittsburgh · Updated on 2025-10-10

450

Participants Needed

15

Research Sites

296 weeks

Total Duration

On this page

Sponsors

U

University of Pittsburgh

Lead Sponsor

D

Duke University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 17Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Civilians and military personnel ages 17 to 50
  • Traumatic anterior shoulder dislocation
  • Subcritical bone loss between 10-20% of the glenoid width confirmed by CT or MRI scan
  • Underwent shoulder instability surgery: arthroscopic Bankart repair with remplissage, open Bankart, or Latarjet
  • Plans to return to physically demanding work, sports, or military duty
Not Eligible

You will not qualify if you...

  • Chronic, non-traumatic multi-directional shoulder instability
  • Concurrent shoulder injuries such as rotator cuff tears, motor nerve issues, or advanced osteoarthritis
  • History of prior shoulder surgery on the involved shoulder including certain instability or rotator cuff repairs
  • Large humeral bone lesions making bony augmentation ineffective
  • Neuromuscular or neurological disorders including seizures
  • Vascular injuries affecting healing or treatment
  • Traumatic brain injury or conditions preventing compliance with post-operative care
  • Cartilage lesions interfering with usual care
  • Known pregnancy at the time of imaging or surgery
  • Problems with the opposite shoulder limiting participation
  • Any condition judged by investigators to limit full study participation
  • No fixed address or contact information
  • Inability to attend all follow-up visits
  • Does not plan to return to pre-injury activity levels

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Actively Recruiting

3

Steadman Clinic

Vail, Colorado, United States, 81657

Actively Recruiting

4

University of Connecticut Health Center

Farmington, Connecticut, United States, 06030

Actively 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

Actively 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

Actively 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

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Research Team

A

Adam Popchak, PhD, PT

CONTACT

J

Jonathan Dickens, MD

CONTACT

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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