Open Versus Arthroscopic Stabilization of Shoulder Instability with Subcritical Bone Loss: the OASIS Trial

Description

This clinical trial will investigate the effects of three surgical procedures and the associated post-operative rehabilitation to optimize 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.

Conditions

Shoulder Dislocation, Glenohumeral Dislocation, Anterior Shoulder Dislocation

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Study Overview

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Study Details

Study overview

This clinical trial will investigate the effects of three surgical procedures and the associated post-operative rehabilitation to optimize 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.

Open Versus Arthroscopic Stabilization of Shoulder Instability with Subcritical Bone Loss: the OASIS Trial

Open Versus Arthroscopic Stabilization of Shoulder Instability with Subcritical Bone Loss: the OASIS Trial

Condition
Shoulder Dislocation
Intervention / Treatment

-

Contacts and Locations

Tempe

Mayo Clinic, Tempe, Arizona, United States, 85288

San Diego

Naval Medical Center, San Diego, California, United States, 92134

Fort Carson

Evans Army Community Hospital, Fort Carson, Colorado, United States, 80913

Vail

Steadman Clinic, Vail, Colorado, United States, 81657

Farmington

University of Connecticut Health Center, Farmington, Connecticut, United States, 06030

Annapolis

US Naval Health Clinic (Academy), Annapolis, Maryland, United States, 21402

Bethesda

Walter Reed National Military Medical Center, Bethesda, Maryland, United States, 20089

Camp Lejeune

Naval Medical Center Camp Lejeune, Camp Lejeune, North Carolina, United States, 28547

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27517

Durham

Duke University, Durham, North Carolina, United States, 27705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Chronic, non-traumatic multi-directional instability based on clinical exam.
  • * Concurrent shoulder injury (e.g. rotator cuff tears, motor nerve pathologies, osteoarthritis of a Samilson-Prieto grade \>2).
  • * Prior instability or rotator cuff procedure on involved shoulder (including intra-articular soft tissue surgery).
  • * Humeral sided bone lesion (Hill-Sachs lesion) that is sufficiently large enough to render the lesion "off-track" even after a bony augmentation procedure would be performed.
  • * Neuromuscular and other movement control pathologies including seizures.
  • * Vascular injury associated with the shoulder trauma.
  • * Traumatic brain injury or any condition that would preclude the ability to comply with post-operative guidelines.
  • * Does not plan to return to pre-injury levels of work, sports or military duty.

Ages Eligible for Study

17 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pittsburgh,

Adam Popchak, PhD, PT, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Jonathan Dickens, MD, PRINCIPAL_INVESTIGATOR, Duke University

James J Irrgang, PhD, PT, ATC, STUDY_CHAIR, University of Pittsburgh

Study Record Dates

2027-09-30