Comparing surgical methods for shoulder instability with bone loss

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

This study tests which of three different shoulder surgeries works best for military and civilian patients with some bone loss, to help them recover faster and get back to their activities.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Ages: 17 Years to 50 Years
• Sex: All
• Sponsor: University of Pittsburgh (other)
• Locations: 15 sites (Tempe, Arizona and 14 other locations)
• Trial ID: NCT04809064 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are military personnel and civilians aged 17 to 50 who have experienced a traumatic anterior shoulder dislocation with 10-20% glenoid bone loss.

Not a fit: Patients with chronic multi-directional instability, significant concurrent shoulder injuries, or other serious medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical options and rehabilitation strategies for patients with shoulder instability, enhancing their recovery and return to active lifestyles.

How similar studies have performed: Other studies have shown promising results with similar surgical approaches for shoulder instability, indicating potential for success in this trial.

Eligibility 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

Where this trial is running

Tempe, Arizona and 14 other locations

• Mayo Clinic — Tempe, Arizona, United States (RECRUITING)
• Naval Medical Center — San Diego, California, United States (RECRUITING)
• Steadman Clinic — Vail, Colorado, United States (RECRUITING)
• University of Connecticut Health Center — Farmington, Connecticut, United States (RECRUITING)
• US Naval Health Clinic (Academy) — Annapolis, Maryland, United States (RECRUITING)
• Walter Reed National Military Medical Center — Bethesda, 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)
• Naval Medical Center Camp Lejeune — Marine Corps Base Camp Lejeune, 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)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)
• Rhode Island Hospital - Brown University Health — Providence, Rhode Island, United States (RECRUITING)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
• San Antonio Military Medical Center — Fort Sam Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Adam Popchak, PhD, PT — University of Pittsburgh
• Study coordinator: Adam Popchak, PhD, PT

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