OASIS Study: Comparison of 3 Different Interventions for Shoulder Instability - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out which type of surgery has the best outcomes for people who have shoulder dislocations with bone loss. There are 3 types of surgeries that doctors can perform to stabilize the shoulder of people who have this type of injury, but there is no evidence at this time that proves one is better than the others. We hope this study can help us figure out how to choose the best option for different patients.

What is the Condition Being Studied?

Shoulder Dislocation and Instability with Bone Loss

Who Can Participate in the Study?

Adults and children ages 17-50 who:
- Have a traumatic anterior shoulder dislocation
- Plan to have surgery to treat their shoulder injury
- Have injury-related glenoid bone loss of 1-20%
- Have not had any previous surgery on the injured shoulder

For more information about who can join this study, please contact the study team at cassandra.rhodes@duke.edu.

Age Group
Adults, Children

What is Involved?

If you choose to join this study, you will get a random assignment (by chance) to have 1 of 3 different surgeries to treat your shoulder injury. The 3 shoulder stabilization surgeries you might be assigned to have done are:
- Bankart repair with remplissage
- Open Bankart repair
- Latarjet procedure

No matter which type of surgery you have, you will also have physical therapy afterward. The type of rehabilitation you do will depend on what surgery you have.

We will ask you to fill out questionnaires related to your recovery for up to 2 years after your surgery. Some of these can be done during your routine follow-up visits or physical therapy appointments, and some can be done online.

Study Details

Full Title
Open Versus Arthroscopic Stabilization of Shoulder Instability with Subcritical Bone Loss
Principal Investigator
Sports Medicine Orthopaedic Surgeon
Protocol Number
IRB: PRO00109283
NCT: NCT04809064
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698