Recruiting

Shoulder Stabilization

Sponsor:

University of Pittsburgh

Code:

NCT04809064

Conditions

Shoulder Dislocation

Glenohumeral Dislocation

Anterior Shoulder Dislocation

Eligibility Criteria

Sex: All

Age: 17 - 50

Healthy Volunteers: Not accepted

Interventions

Arthroscopic Bankart repair procedure

Open Bankart

Latarjet

Post-Operative Rehabilitation

Study Details

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.

Conditions

Shoulder Dislocation

Glenohumeral Dislocation

Anterior Shoulder Dislocation

Study ID

NCT04809064

Start date

Jan 24, 2022

Status verified date

May, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 17 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

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

Arthroscopic Bankart repair procedure

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

Open Bankart

Open Bankart repair consists of anterior capsulorrhaphy with labral repair.

Latarjet

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

Post-Operative Rehabilitation

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

Primary outcome measure

  • Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 3 months after surgery ]
  • Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 6 months after surgery ]
  • Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 12 months after surgery ]
  • Western Ontario Shoulder Instability Index (WOSI) [ Time Frame: 24 months after surgery ]
  • Time to Return to Pre-Injury Level of Activity [ Time Frame: Monthly starting at 3 months after surgery and continuing to 24 months ]
  • Recurrent Instability / Re-injury [ Time Frame: 3 months after surgery ]
  • Recurrent Instability / Re-injury [ Time Frame: 6 months after surgery ]
  • Recurrent Instability / Re-injury [ Time Frame: 12 months after surgery ]
  • Recurrent Instability / Re-injury [ Time Frame: 24 months after surgery ]

Central Contacts and Locations

Central contacts

Adam Popchak, PhD, PT

(412) 383-6627ajp64@pitt.edu

Locations

Mayo Clinic

Recruiting

Tempe, Arizona, United States, 85288

Contacts

John Tokish, MD

tokish.john@mayo.edu

Principal Investigator:

John Tokish, MD

US Naval Health Clinic (Academy)

Recruiting

Annapolis, Maryland, United States, 21402

Contacts

Robert Waltz, MC, USN

lancend15@gmail.com

Principal Investigator:

Robert Waltz, MC, USN

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27517

Contacts

Alex Creighton, MD

alex_creighton@med.unc.edu

Principal Investigator:

Alex Creighton, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Jonathan Dickens, MD

jonathan.dickens@duke.edu

Principal Investigator:

Brian Lau, MD

Wake Forest University

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Brian Waterman, MD

bwaterma@wakehealth.edu

Principal Investigator:

Brian Waterman, MD

Ohio State University, Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43202

Contacts

Julie Bishop, MD

julie.bishop@osumc.edu

Principal Investigator:

Julie Bishop, MD

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15203

Contacts

Albert Lin, MD

alin2@upmc.edu

Principal Investigator:

Albert Lin, MD

Rhode Island Hospital - Brown University Health

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Stephen Marcaccio, MD

smarcaccio@uoi.com

Principal Investigator:

Stephen Marcaccio, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Lance LeClere, MD

lancend15@gmail.com

Principal Investigator:

Lance LeClere, MD

San Antonio Military Medical Center

Recruiting

Fort Sam Houston, Texas, United States, 78234

Contacts

Daniel J Cognetti, MD

daniel.j.cognetti.mil@health.mil

Principal Investigator:

Daniel J Cognetti, MD

More Information

Sponsor

University of Pittsburgh

Last update posted

Jun 8, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-06-08.