OASIS Study: Comparison of 3 Different Interventions for Shoulder Instability

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. This is an observational study and participation will not affect the treatment option you choose to pursue.

Who Can Participate?

Eligibility

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 or 919-660-9301.

Age Range

18-50

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you and your doctor will choose 1 of the 3 standard surgeries to repair your shoulder:
  • Bankart repair with remplissage; OR
  • Open Bankart repair; OR
  • 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. Participation in this study will have no effect on what procedure you and your doctor can choose to treat your shoulder. 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.

Locations

Other

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

Open Versus Arthroscopic Stabilization of Shoulder Instability with Subcritical Bone Loss

Principal Investigator

Brian
Lau

Protocol Number

PRO00109283

NCT ID

NCT04809064

Phase

N/A

Enrollment Status

Open to Enrollment
ClinicalTrials.gov