Comparing surgical methods for shoulder instability with bone loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of three surgical procedures for treating shoulder instability in military personnel and civilians with 10-20% glenoid bone loss. Participants will be randomly assigned to receive either arthroscopic Bankart repair with remplissage, open Bankart repair, or Latarjet procedure, followed by a tailored rehabilitation program. The study aims to optimize recovery time and improve patient-reported outcomes related to physical function and return to duty or sports activities.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic
  Tempe, Arizona, United States Recruiting
• US Naval Health Clinic (Academy)
  Annapolis, Maryland, United States Recruiting
• University of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• Duke University
  Durham, North Carolina, United States Recruiting
• Wake Forest University
  Winston-Salem, North Carolina, United States Recruiting
• Ohio State University, Wexner Medical Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Adam Popchak, PhD, PT — University of Pittsburgh
• Study coordinator: Adam Popchak, PhD, PT
• Email: ajp64@pitt.edu
• Phone: (412) 383-6627

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.