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Procedure

Shoulder Stabilization Surgery for Shoulder Dislocation (OASIS Trial)

N/A
Recruiting
Led By Adam Popchak, PhD, PT
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Traumatic anterior shoulder dislocation
Be younger than 65 years old
Must not have
Prior instability or rotator cuff procedure on involved shoulder (including intra-articular soft tissue surgery)
Concurrent shoulder injury (e.g. rotator cuff tears, motor nerve pathologies, osteoarthritis of a Samilson-Prieto grade >2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly starting at 3 months after randomization and continuing to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare 3 surgical procedures and post-op rehab for people with shoulder instability and some glenoid bone loss. The goal is to help them return to military duty, work, and sports.

Who is the study for?
This trial is for civilians and military personnel aged 17 to 50 with traumatic anterior shoulder instability and subcritical bone loss of 10-20% in the glenoid. Participants must be able to follow post-op guidelines and aim to return to their pre-injury activity levels. Those with brain injuries, vascular shoulder injuries, large humeral lesions, chronic instability, additional shoulder injuries, or prior surgeries on the affected shoulder are excluded.
What is being tested?
The OASIS Trial compares three surgical techniques—Open Bankart repair, Arthroscopic Bankart repair procedure, Latarjet—and their subsequent rehabilitation programs. The goal is to determine which method best reduces recovery time and improves physical function after a traumatic shoulder dislocation with minor bone loss.
What are the potential side effects?
Potential side effects from these surgical procedures may include pain at the surgery site, infection risk, limited range of motion during recovery period, complications related to anesthesia use during surgery as well as risks associated with post-operative rehabilitation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a shoulder dislocation due to injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery or issues with my shoulder's rotator cuff.
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I do not have a serious shoulder injury.
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My joints are unstable in many directions without any injury causing it.
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I have a blood vessel injury related to shoulder injury.
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I can follow post-surgery instructions despite my brain injury.
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My shoulder injury is too severe to be fixed with bone surgery alone.
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I have a condition that affects my muscle control or causes seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly starting at 3 months after randomization and continuing to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly starting at 3 months after randomization and continuing to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrent Instability / Re-injury
Time to Return to Pre-Injury Level of Activity
Western Ontario Shoulder Instability Index (WOSI)
Secondary study objectives
Brief Resilience Scale
Brophy Shoulder Activity Level
Dental Implantation, Endosseous, Endodontic
+18 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Open Bankart/rehabilitationExperimental Treatment2 Interventions
Open Bankart surgery and post-operative rehabilitation.
Group II: Latarjet/rehabilitationExperimental Treatment2 Interventions
Latarjet surgical procedure and post-operative rehabilitation.
Group III: Arthroscopic Bankart repair with remplissage of Hill-Sachs lesion/rehabilitationExperimental Treatment2 Interventions
Arthroscopic Bankart repair surgery with remplissage of Hill-Sachs lesion and post-operative rehabilitation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Latarjet
2021
N/A
~120

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,792 Previous Clinical Trials
16,359,586 Total Patients Enrolled
Walter Reed National Military Medical CenterFED
143 Previous Clinical Trials
32,927 Total Patients Enrolled
Adam Popchak, PhD, PTPrincipal InvestigatorUniversity of Pittsburgh
Jonathan Dickens, MDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
100 Total Patients Enrolled
James J Irrgang, PhD, PT, ATCStudy ChairUniversity of Pittsburgh

Media Library

Arthroscopic Bankart repair procedure (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04809064 — N/A
Shoulder Dislocation Research Study Groups: Arthroscopic Bankart repair with remplissage of Hill-Sachs lesion/rehabilitation, Open Bankart/rehabilitation, Latarjet/rehabilitation
Shoulder Dislocation Clinical Trial 2023: Arthroscopic Bankart repair procedure Highlights & Side Effects. Trial Name: NCT04809064 — N/A
Arthroscopic Bankart repair procedure (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04809064 — N/A
~188 spots leftby Sep 2027
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