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

Study Purpose

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.

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.

Interventional
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.

Exclusion Criteria:

  • - 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.

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.

N/A
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, ATC
Principal Investigator Affiliation University of PittsburghDuke UniversityUniversity of Pittsburgh
Agency Class

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

Other, U.S. Fed
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 clinical trial is to determine the optimal surgical procedure and post-operative rehabilitation strategy for treatment of military personnel and civilians with shoulder instability and subcritical bone loss. Investigators will conduct a randomized, controlled trial comparing arthroscropic Bankart with remplissage/rehabilitation versus open Bankart/rehabilitation versus Latarjet/rehabilitation. Aim 1: The investigators will determine the effects of arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion versus open Bankart versus Latarjet on patient reported outcomes (Western Ontario Shoulder Instability score [WOSI]), time to Return to Duty/Activity (RTD/A) at pre-injury levels, and recurrent instability/re-injury at 6 months, 1 and 2 years. 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 and plans to return to physically demanding work or sports, 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. Study / Experimental Design: Randomized controlled trial (Aim 1), Prospective cohort (Aim 2). Methodology: 450 individuals will be randomized to arthroscopic Bankart with remplissage of a Hill-Sachs lesion/rehabilitation vs.#46; open Bankart/rehabilitation vs.#46; open Latarjet/rehabilitation. To address Aim 1, individuals with traumatic anterior shoulder instability with subcritical bone loss will be randomized to arthroscopic Bankart repair with remplissageof a Hill-Sachs lesion, or open Bankart, or Latarjet. To address Aim 2, all individuals will enter into rehabilitation with specific instructions for the first 12 weeks dependent on the surgical arm to which they are randomized. After week 12, all rehabilitation programs will be similar and progressed based upon the results of interim testing at 3, 4, and 6 months. 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

Experimental: Arthroscopic Bankart repair with remplissage of Hill-Sachs lesion/rehabilitation

Arthroscopic Bankart repair surgery with remplissage of Hill-Sachs lesion and post-operative rehabilitation.

Experimental: Open Bankart/rehabilitation

Open Bankart surgery and post-operative rehabilitation.

Experimental: 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, Arizona

Status

Not yet recruiting

Address

Mayo Clinic

Tempe, Arizona, 85288

Site Contact

John Tokish, MD

[email protected]

(412) 383-6627

Naval Medical Center, San Diego, California

Status

Not yet recruiting

Address

Naval Medical Center

San Diego, California, 92134

Site Contact

Lucas McDonald, MD

[email protected]

(412) 383-6627

Evans Army Community Hospital, Fort Carson, Colorado

Status

Not yet recruiting

Address

Evans Army Community Hospital

Fort Carson, Colorado, 80913

Site Contact

David Tennent, MD

[email protected]

(412) 383-6627

Steadman Clinic, Vail, Colorado

Status

Recruiting

Address

Steadman Clinic

Vail, Colorado, 81657

Site Contact

Matthew Provencher, MD

[email protected]

(412) 383-6627

University of Connecticut Health Center, Farmington, Connecticut

Status

Recruiting

Address

University of Connecticut Health Center

Farmington, Connecticut, 06030

Site Contact

Cory Edgar, MD, PhD

[email protected]

(412) 383-6627

US Naval Health Clinic (Academy), Annapolis, Maryland

Status

Not yet recruiting

Address

US Naval Health Clinic (Academy)

Annapolis, Maryland, 21402

Site Contact

Robert Waltz, MC, USN

[email protected]

(412) 383-6627

Bethesda, Maryland

Status

Not yet recruiting

Address

Walter Reed National Military Medical Center

Bethesda, Maryland, 20089

Site Contact

Kelly Kilcoyne, MD

[email protected]

(412) 383-6627

Naval Medical Center Camp Lejeune, Camp Lejeune, North Carolina

Status

Not yet recruiting

Address

Naval Medical Center Camp Lejeune

Camp Lejeune, North Carolina, 28547

Site Contact

Kyle Nappo, MD

[email protected]

(412) 383-6627

Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27517

Site Contact

Alex Creighton, MD

[email protected]

(412) 383-6627

Duke University, Durham, North Carolina

Status

Recruiting

Address

Duke University

Durham, North Carolina, 27705

Site Contact

Jonathan Dickens, MD

[email protected]

(412) 383-6627

Wake Forest University, Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest University

Winston-Salem, North Carolina, 27157

Site Contact

Brian Waterman, MD

[email protected]

(412) 383-6627

Columbus, Ohio

Status

Recruiting

Address

Ohio State University, Wexner Medical Center

Columbus, Ohio, 43202

Site Contact

Julie Bishop, MD

[email protected]

(412) 383-6627

University of Pittsburgh, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh

Pittsburgh, Pennsylvania, 15203

Site Contact

Albert Lin, MD

[email protected]

(412) 383-6627

Providence, Rhode Island

Status

Recruiting

Address

Rhode Island Hospital - University Orthopedics

Providence, Rhode Island, 02903

Site Contact

Brett Owens, MD

[email protected]

(412) 383-6627

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Not yet recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Site Contact

Lance LeClere, MD

[email protected]

(412) 383-6627

San Antonio Military Medical Center, Fort Sam Houston, Texas

Status

Not yet recruiting

Address

San Antonio Military Medical Center

Fort Sam Houston, Texas, 78234

Site Contact

Andrew Sheean, MD

[email protected]

(412) 383-6627

University of Virginia, Charlottesville, Virginia

Status

Not yet recruiting

Address

University of Virginia

Charlottesville, Virginia, 22904

Site Contact

Stephen Brockmeier, MD

[email protected]

(412) 383-6627