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:<ul>
<li>Have a traumatic anterior shoulder dislocation</li>
<li>Plan to have surgery to treat their shoulder injury</li>
<li>Have injury-related glenoid bone loss of 1-20%</li>
<li>Have not had any previous surgery on the injured shoulder</li></ul>
For more information about who can join this study, please contact the study team at Cassandra.Rhodes@duke.edu or 919-660-9301.
<li>Have a traumatic anterior shoulder dislocation</li>
<li>Plan to have surgery to treat their shoulder injury</li>
<li>Have injury-related glenoid bone loss of 1-20%</li>
<li>Have not had any previous surgery on the injured shoulder</li></ul>
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?
If you choose to join this study, you and your doctor will choose 1 of the 3 standard surgeries to repair your shoulder:<ul>
<li>Bankart repair with remplissage; OR</li>
<li>Open Bankart repair; OR</li>
<li>Latarjet procedure</li></ul>
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.
<li>Bankart repair with remplissage; OR</li>
<li>Open Bankart repair; OR</li>
<li>Latarjet procedure</li></ul>
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