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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 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.

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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.

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

FieldValue
Enrollment Target 450 participants
Start Date 2022-01-24
Est. Completion 2027-09-30

Sponsor

University of Pittsburgh

1,238 total trials

What the Registry Record Tells You About NCT04809064

The ClinicalTrials.gov registry entry for NCT04809064 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 93-participant average among 3 other Shoulder Dislocation trials with a reported enrollment target (384% higher). The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.

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 reports 15 study locations spanning 11 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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