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

NCT04809064 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2025-10-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Adam Popchak, PhD, PT · University of Pittsburgh

  • Jonathan Dickens, MD · Duke University

  • James J Irrgang, PhD, PT · University of Pittsburgh

Eligibility

Min Age
17 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-24
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04809064 on ClinicalTrials.gov