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NCT04809064 · ClinicalTrials.gov registry record
Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial
A clinical trial of Shoulder Dislocation and Glenohumeral Dislocation, sponsored by University of Pittsburgh.
- Recruiting
- Registry status
- 450
- Enrollment target
- 15
- Study locations
NCT04809064: Recruiting study of Shoulder Dislocation and Glenohumeral Dislocation, sponsored by University of Pittsburgh.
NCT04809064 is a study of Shoulder Dislocation and Glenohumeral Dislocation that is actively recruiting participants, run by University of Pittsburgh. The registered enrollment target is 450 participants, above the 93-participant average among 3 other Shoulder Dislocation trials with a reported enrollment target (384% higher). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04809064, a study of Shoulder Dislocation and Glenohumeral Dislocation, is actively recruiting participants, sponsored by University of Pittsburgh.
- RECRUITING
- Registry status
- 450 participants
- Enrollment target
- 15
- Study locations
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.
Primary Outcome
The Western Ontario Shoulder Instability Index (WOSI) is a 21-item instability-specific patient-reported outcome measure of physical symptoms, sports, recreation, work, lifestyle and emotions. The best possible score is 0 and a worst possible score is 2100. The WOSI was found to be responsive and sensitive to detecting change over time, demonstrating its utility as a primary outcome to evaluate treatments and to monitor participants' progress over time.
Conditions Studied
Interventions
- PROCEDURE Arthroscopic Bankart repair procedure
- PROCEDURE Open Bankart
- PROCEDURE Latarjet
- OTHER Post-Operative Rehabilitation
Study Locations (15)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
- Duke University - Durham
- Naval Medical Center Camp Lejeune - Marine Corps Base Camp Lejeune
- Wake Forest University - Winston-Salem
Maryland
- US Naval Health Clinic (Academy) - Annapolis
- Walter Reed National Military Medical Center - Bethesda
Arizona
- Mayo Clinic - Tempe
California
- Naval Medical Center - San Diego
Colorado
- Steadman Clinic - Vail
Connecticut
- University of Connecticut Health Center - Farmington
Ohio
- Ohio State University, Wexner Medical Center - Columbus
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2022-01-24 |
| Est. Completion | 2027-09-30 |
What NCT04809064 shows while recruiting
NCT04809064 is an observational study that tracks outcomes without assigning an intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 93-participant average among 3 other Shoulder Dislocation trials with a reported enrollment target (384% higher).
The record links to 3 conditions, with Shoulder Dislocation appearing as the primary indexed condition, and to 4 interventions - of which Arthroscopic Bankart repair procedure is the first listed.
NCT04809064 lists 15 locations in 11 states (North Carolina, Maryland, Arizona).
Frequently Asked Questions
What is clinical trial NCT04809064 about?
NCT04809064 is a clinical study titled "Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial". 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 sh...
What is the current status of trial NCT04809064?
This trial is currently recruiting. The enrollment target is 450 participants. The study started on 2022-01-24. Estimated completion is 2027-09-30.
What conditions does trial NCT04809064 study?
This clinical trial studies the following conditions: Shoulder Dislocation, Glenohumeral Dislocation, Anterior Shoulder Dislocation.
What interventions are being tested in trial NCT04809064?
The interventions under investigation include: Arthroscopic Bankart repair procedure (PROCEDURE), Open Bankart (PROCEDURE), Latarjet (PROCEDURE), Post-Operative Rehabilitation (OTHER).
Who is sponsoring clinical trial NCT04809064?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04809064 being conducted?
This trial has 15 study locations across Arizona, California, Colorado, Connecticut, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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