RECRUITING

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

Conditions

Shoulder Dislocation Glenohumeral Dislocation Anterior Shoulder Dislocation Anterior Shoulder Instability Glenoid Bone Loss Stabilization Surgery Return to Duty or Sport Rehabilitation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-01-24

Study Completion:2027-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04809064

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.

Ages Eligible for Study:17 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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, 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	* 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) * Have a history of shoulder surgery in the involved shoulder (prior instability surgery that included any of the following and the planned procedure would be a repeat of the index procedure: 1) arthroscopic Bankart repair with a remplissage of Hill-Sachs lesion, 2) open Bankart, or 3) Latarjet \[previous isolated arthroscopic Bankart repair only would not be an exclusion criterion\], rotator cuff repair, intra-articular soft tissue surgery); rotator cuff repair, intra-articular soft tissue surgery) * 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

Inclusion Criteria

Exclusion 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, 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

* 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)
* Have a history of shoulder surgery in the involved shoulder (prior instability surgery that included any of the following and the planned procedure would be a repeat of the index procedure: 1) arthroscopic Bankart repair with a remplissage of Hill-Sachs lesion, 2) open Bankart, or 3) Latarjet \[previous isolated arthroscopic Bankart repair only would not be an exclusion criterion\], rotator cuff repair, intra-articular soft tissue surgery); rotator cuff repair, intra-articular soft tissue surgery)
* 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

Contacts and Locations

Study Contact

Adam Popchak, PhD, PT

CONTACT

(412) 383-6627

ajp64@pitt.edu

Jonathan Dickens, MD

CONTACT

Principal Investigator

Adam Popchak, PhD, PT

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Jonathan Dickens, MD

PRINCIPAL_INVESTIGATOR

Duke University

James J Irrgang, PhD, PT

STUDY_CHAIR

University of Pittsburgh

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Pittsburgh

Adam Popchak, PhD, PT, PRINCIPAL_INVESTIGATOR, University of Pittsburgh
Jonathan Dickens, MD, PRINCIPAL_INVESTIGATOR, Duke University
James J Irrgang, PhD, PT, STUDY_CHAIR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-24

Study Completion Date2027-09-30

Study Record Updates

Study Start Date2022-01-24

Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

Anterior Shoulder Instability
Glenoid Bone Loss
Stabilization Surgery
Return to Duty or Sport
Rehabilitation

Additional Relevant MeSH Terms

Shoulder Dislocation
Glenohumeral Dislocation
Anterior Shoulder Dislocation