Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial
OASIS
2 other identifiers
observational
450
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2021
CompletedFirst Posted
Study publicly available on registry
March 22, 2021
CompletedStudy Start
First participant enrolled
January 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
October 10, 2025
October 1, 2025
5.7 years
March 17, 2021
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Western Ontario Shoulder Instability Index (WOSI)
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
3 months after surgery
Western Ontario Shoulder Instability Index (WOSI)
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
6 months after surgery
Western Ontario Shoulder Instability Index (WOSI)
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
12 months after surgery
Western Ontario Shoulder Instability Index (WOSI)
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
24 months after surgery
Time to Return to Pre-Injury Level of Activity
Time to return to pre-injury level military duty, work and sports.
Monthly starting at 3 months after surgery and continuing to 24 months
Recurrent Instability / Re-injury
Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.
3 months after surgery
Recurrent Instability / Re-injury
Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.
6 months after surgery
Recurrent Instability / Re-injury
Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.
12 months after surgery
Recurrent Instability / Re-injury
Recurrent instability will consist of any of the following events: dislocation, subluxation, revision stabilization procedure.
24 months after surgery
Secondary Outcomes (77)
Single Assessment Numerical Evaluation (SANE)
3 months after surgery
Single Assessment Numerical Evaluation (SANE)
6 months after surgery
Single Assessment Numerical Evaluation (SANE)
12 months after surgery
Single Assessment Numerical Evaluation (SANE)
24 months after surgery
Brophy Shoulder Activity Level
3 months after surgery
- +72 more secondary outcomes
Study Arms (3)
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.
Interventions
Bankart repair with remplissage consists of arthroscopic anterior inferior capsulolabral repair with arthroscopic infraspinatus tenodesis to the posterior humeral head.
Open Bankart repair consists of anterior capsulorrhaphy with labral repair.
Latarjet consists of open transfer of the coracoid to the anterior glenoid bone deficiency.
Post-operative rehabilitation will be conducted following surgical procedure-specific rehabilitation guidelines and will be progressed based on individual needs.
Eligibility Criteria
Male and female military personnel and civilians between the ages of 17 and 50 with a traumatic anterior shoulder dislocation with associated 10-20% glenoid bone loss, having undergone either an 1) arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, 2) open Bankart, or a 3) Latarjet, and plans to return to physically demanding work or sports.
You may qualify if:
- 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
You may not qualify if:
- Chronic, non-traumatic multi-directional instability based on clinical exam
- Concurrent shoulder injury in the involved shoulder (e.g., rotator cuff tears, motor nerve pathologies, osteoarthritis of a Samilson-Prieto grade \>2)
- Prior rotator cuff procedure on involved shoulder (including intra-articular soft tissue surgery
- Humeral sided bone lesions (Hill-Sachs lesion) that is sufficiently large enough to render the lesion "off-track" even after a bony augmentation procedure would be performed
- Neuromuscular, neurological and other movement control pathologies including seizures
- Vascular injury associated with the shoulder trauma that compromise adequate/normal healing or interferes with usual course of care
- Traumatic brain injury or any condition that would preclude the ability to comply with post-operative guidelines
- Cartilage lesion finding in the involved shoulder that would interfere with usual course of care
- Known pregnancy at time of imagining and/or surgery based upon standard of care testing procedures
- Any issue with the contralateral shoulder that would preclude participation in research procedures
- Any condition in the opinion of the investigator/clinician that would preclude or limit full participation in study activities
- Absence of a fixed address or no means of contact
- Known inability to be available at all follow-up time points
- Does not plan to return to pre-injury levels of work, sports or military duty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Duke Universitycollaborator
Study Sites (15)
Mayo Clinic
Tempe, Arizona, 85288, United States
Naval Medical Center
San Diego, California, 92134, United States
Steadman Clinic
Vail, Colorado, 81657, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
US Naval Health Clinic (Academy)
Annapolis, Maryland, 21402, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20089, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517, United States
Duke University
Durham, North Carolina, 27705, United States
Naval Medical Center Camp Lejeune
Marine Corps Base Camp Lejeune, North Carolina, 28547, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Ohio State University, Wexner Medical Center
Columbus, Ohio, 43202, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15203, United States
Rhode Island Hospital - Brown University Health
Providence, Rhode Island, 02903, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Popchak, PhD, PT
University of Pittsburgh
- PRINCIPAL INVESTIGATOR
Jonathan Dickens, MD
Duke University
- STUDY CHAIR
James J Irrgang, PhD, PT
University of Pittsburgh
Central Study Contacts
Jonathan Dickens, MD
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 17, 2021
First Posted
March 22, 2021
Study Start
January 24, 2022
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
October 10, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The public-use version of the dataset will be made available 2 years after the study's main paper is published.
- Access Criteria
- Outside investigators wishing to conduct analyses using the data will submit a request with objectives, methods, and analysis plan to the PI and the Director of the DCC. Once the request is approved, the public-use version of the dataset, with documentation, will be sent by secure email using e-mail, ftp, or other mutually agreeable transmission method.
A public-use version of the dataset will be constructed by the Data Coordinating Center (DCC) with contents to be determined jointly by the study PIs and the DCC Director. Copies of the public-use version of the dataset will be housed at the DCC on a secure server along with suitable documentation of this dataset. The public-use version of the dataset will be exported in one or more files in simple, widely-accessible formats, e.g., .xls, .csv, and/or Statistical Analysis Software (SAS) datasets. Documentation will be in .pdf files.