NCT04809064

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 17 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective of this study is to 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 military personnel and civilians with acute or recurrent anterior shoulder instability with subcritical bone loss. Aim 1: The investigators will determine the acute and long term patient relevant outcomes (Western Ontario Shoulder Instability score \[WOSI\], time to RTD/A at pre-injury levels, and recurrent instability/re-injury) at 6 months, 1, and 2 years of arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, and Latarjet. 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, having undergone either an 1) arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, 2) open Bankart, or a 3) Latarjet, and plans to return to physically demanding work or sports. Study / Experimental Design: Prospective Observational Cohort Study (Aims 1 \& 2). Methodology: Participants will undergo a standard of care computed tomography (CT) or 3D-MRI scan to quantify glenoid bone loss and shoulders with between 10-20% bone loss will be offered enrollment. We will allow shared decision-making between the patient-participant and the surgeon to occur in order to select the surgical stabilization procedure (arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, or Latarjet). Only those patients having one of the three surgeries will be eligible for this study. Therefore, 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, plans to return to physically demanding work or sports, and having undergone one of the three surgeries listed above 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. We will collect information from the surgeon into what individual factors influenced the decision on surgical selection for each patient-participant. To address the associated aims, 450 individuals will recruited and enrolled to participate in this study. 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.

Conditions

• Shoulder Dislocation
• Glenohumeral Dislocation
• Anterior Shoulder Dislocation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-24
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2021-03-22
• Last updated: 2025-10-10

Locations

15 sites across 1 country: United States