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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
Civilians and military personnel ages 17 to 50
Traumatic anterior shoulder dislocation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly starting at 3 months after randomization and continuing to 24 months
Awards & highlights

OASIS Trial 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.Check my eligibility
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.See study design
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.

OASIS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 17 and 50 years old.
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I have had a shoulder dislocation due to injury.

OASIS Trial 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

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

OASIS 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.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,716 Previous Clinical Trials
16,346,054 Total Patients Enrolled
Walter Reed National Military Medical CenterFED
136 Previous Clinical Trials
36,935 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the upper age limit of this trial extend beyond eighty five years?

"The study's criteria for admission states that those hoping to join must be between 17 and 50 years old."

Answered by AI

How many participants are accepted into this trial at its peak capacity?

"Correct. According to the clinicaltrials.gov website, this research effort was first published on January 24th 2022 and is currently recruiting participants. 400 individuals need to be enrolled at 12 distinct medical institutions."

Answered by AI

What specific goals are researchers attempting to achieve with this experiment?

"The primary endpoint for this investigation, observed over a period of 24 months post randomization, is the Western Ontario Shoulder Instability Index (WOSI). Secondary outcomes include Single Assessment Numerical Evaluation (SANE), Brophy Shoulder Activity Level and Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function - Upper Extremity. The SANE scale boasts excellent reliability with an ICC greater than 0.80; validity displays moderate to strong correlations ranging between 0.50 and 0.88 compared to other patient reported outcome measures while its Standard Error of Measurement ranges from 4.23 to 7.82"

Answered by AI

What is the extent of hospital involvement in this clinical trial?

"The current study has sites in Providence, Charlottesville, and Vail. Additionally, there are 12 other clinical trial sites operating for this research project."

Answered by AI

Is this particular trial actively seeking participants?

"As indicated on clinicaltrials.gov, enrollment for this medical trial is currently ongoing. The study was first advertised on the 24th of January 2022 and its most recent update was made available on September 9th 2022."

Answered by AI

Which demographic would most benefit from enrolling in this clinical investigation?

"This clinical trial aims to recruit 400 individuals between 17 and 50 years old that present with shoulder dislocation. Additionally, the candidate must have a bone loss of 10-20% lower than glenoid width as quantified by standard CT scan imaging technology. This study is open to both civilians and military personnel."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
What site did they apply to?
Evans Army Community Hospital
San Antonio Military Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
~65 spots leftby Sep 2024