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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 17 Years - 50 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion 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.

Exclusion Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04809064
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Pittsburgh
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Adam Popchak, PhD, PTJonathan Dickens, MDJames J Irrgang, PhD, PT
Principal Investigator Affiliation University of PittsburghDuke UniversityUniversity of Pittsburgh
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Shoulder Dislocation, Glenohumeral Dislocation, Anterior Shoulder Dislocation
Additional Details

The objective of this study is to 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 military personnel and civilians with acute or recurrent anterior shoulder instability with subcritical bone loss. Aim 1: The investigators will determine the acute and long term patient relevant outcomes (Western Ontario Shoulder Instability score [WOSI], time to RTD/A at pre-injury levels, and recurrent instability/re-injury) at 6 months, 1, and 2 years of arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, and Latarjet. Aim 2: The investigators will determine if participation in rehabilitation that optimizes range of motion, strength, and functional performance predicts successful RTD/A, WOSI score, and recurrent instability at 6 months, 1, and 2 years. Subject Population: 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. Study / Experimental Design: Prospective Observational Cohort Study (Aims 1 & 2). Methodology: Participants will undergo a standard of care computed tomography (CT) or 3D-MRI scan to quantify glenoid bone loss and shoulders with between 10-20% bone loss will be offered enrollment. We will allow shared decision-making between the patient-participant and the surgeon to occur in order to select the surgical stabilization procedure (arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, or Latarjet). Only those patients having one of the three surgeries will be eligible for this study. Therefore, 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, plans to return to physically demanding work or sports, and having undergone one of the three surgeries listed above without multi-directional instability, concomitant shoulder pathologies (e.g. rotator cuff tears, motor nerve lesion, fractures, osteoarthritis > Samilson Pietro grade 2), neuromuscular conditions including seizures, a history of shoulder surgery related to any intraarticular soft tissue, and vascular injury will be eligible to participate. We will collect information from the surgeon into what individual factors influenced the decision on surgical selection for each patient-participant. To address the associated aims, 450 individuals will recruited and enrolled to participate in this study. Participants will be followed for 24 months, with primary outcomes consisting of patient-reported physical function and time to return to pre-injury military duty, work and sports. Secondary outcomes will include shoulder-specific and generic patient-reported measures of physical function and health related quality of life and recurrent instability.

Arms & Interventions

Arms

: 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

Procedure: - Arthroscopic Bankart repair procedure

Bankart repair with remplissage consists of arthroscopic anterior inferior capsulolabral repair with arthroscopic infraspinatus tenodesis to the posterior humeral head.

Procedure: - Open Bankart

Open Bankart repair consists of anterior capsulorrhaphy with labral repair.

Procedure: - Latarjet

Latarjet consists of open transfer of the coracoid to the anterior glenoid bone deficiency.

Other: - Post-Operative Rehabilitation

Post-operative rehabilitation will be conducted following surgical procedure-specific rehabilitation guidelines and will be progressed based on individual needs.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Tempe 5317058, Arizona 5551752

Status

Recruiting

Address

Mayo Clinic

Tempe 5317058, Arizona 5551752, 85288

Site Contact

John Tokish, MD

[email protected]

(412) 383-6627

Naval Medical Center, San Diego 5391811, California 5332921

Status

Recruiting

Address

Naval Medical Center

San Diego 5391811, California 5332921, 92134

Site Contact

Lucas McDonald, MD

[email protected]

(412) 383-6627

Steadman Clinic, Vail 5442727, Colorado 5417618

Status

Recruiting

Address

Steadman Clinic

Vail 5442727, Colorado 5417618, 81657

Site Contact

Matthew Provencher, MD

[email protected]

(412) 383-6627

University of Connecticut Health Center, Farmington 4834272, Connecticut 4831725

Status

Recruiting

Address

University of Connecticut Health Center

Farmington 4834272, Connecticut 4831725, 06030

Site Contact

Cory Edgar, MD, PhD

[email protected]

(412) 383-6627

US Naval Health Clinic (Academy), Annapolis 4347242, Maryland 4361885

Status

Recruiting

Address

US Naval Health Clinic (Academy)

Annapolis 4347242, Maryland 4361885, 21402

Site Contact

Robert Waltz, MC, USN

[email protected]

(412) 383-6627

Bethesda 4348599, Maryland 4361885

Status

Recruiting

Address

Walter Reed National Military Medical Center

Bethesda 4348599, Maryland 4361885, 20089

Site Contact

Daniel J Song, MD, LTC

[email protected]

(412) 383-6627

Chapel Hill 4460162, North Carolina 4482348

Status

Recruiting

Address

University of North Carolina at Chapel Hill

Chapel Hill 4460162, North Carolina 4482348, 27517

Site Contact

Alex Creighton, MD

[email protected]

(412) 383-6627

Duke University, Durham 4464368, North Carolina 4482348

Status

Recruiting

Address

Duke University

Durham 4464368, North Carolina 4482348, 27705

Site Contact

Jonathan Dickens, MD

[email protected]

(412) 383-6627

Naval Medical Center Camp Lejeune, Marine Corps Base Camp Lejeune 7267550, North Carolina 4482348

Status

Recruiting

Address

Naval Medical Center Camp Lejeune

Marine Corps Base Camp Lejeune 7267550, North Carolina 4482348, 28547

Site Contact

Margaret A Harvey, DO

[email protected]

(412) 383-6627

Wake Forest University, Winston-Salem 4499612, North Carolina 4482348

Status

Recruiting

Address

Wake Forest University

Winston-Salem 4499612, North Carolina 4482348, 27157

Site Contact

Brian Waterman, MD

[email protected]

(412) 383-6627

Columbus 4509177, Ohio 5165418

Status

Recruiting

Address

Ohio State University, Wexner Medical Center

Columbus 4509177, Ohio 5165418, 43202

Site Contact

Julie Bishop, MD

[email protected]

(412) 383-6627

University of Pittsburgh, Pittsburgh 5206379, Pennsylvania 6254927

Status

Recruiting

Address

University of Pittsburgh

Pittsburgh 5206379, Pennsylvania 6254927, 15203

Site Contact

Albert Lin, MD

[email protected]

(412) 383-6627

Providence 5224151, Rhode Island 5224323

Status

Recruiting

Address

Rhode Island Hospital - Brown University Health

Providence 5224151, Rhode Island 5224323, 02903

Site Contact

Stephen Marcaccio, MD

[email protected]

(412) 383-6627

Vanderbilt University Medical Center, Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville 4644585, Tennessee 4662168, 37232

Site Contact

Lance LeClere, MD

[email protected]

(412) 383-6627

San Antonio Military Medical Center, Fort Sam Houston 7267736, Texas 4736286

Status

Recruiting

Address

San Antonio Military Medical Center

Fort Sam Houston 7267736, Texas 4736286, 78234

Site Contact

Daniel J Cognetti, MD

[email protected]

(412) 383-6627