Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05344898
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2022-04-06
Brief Title:
Subscap Reverse Shoulder Arthroplasty
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Subscapularis Repair in Reverse Shoulder Arthroplasty A Multi-Center Randomized Single Blinded Superiority Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The subscapularis is part of the rotator cuff and is release as part of a reverse shoulder replacement The decision to repair this tendon is controversial This research is being done to help determine if rotator cuff repair improves or hinders shoulder replacement A worrisome but rare complication after shoulder replacement is dislocation Rotator cuff repair may help reduce this risk The repair may hinder some of the range of motion afterwards or could help with internal rotation strength There is a chance that the repair doesnt matter at all The goal of this study is to delineate outcomes after reverse shoulder arthroplasty with the respect to management of the subscapularis tendon Further information about rotator cuff repair after reverse shoulder replacement can help define complications potentially decrease OR time and improve functional outcomes A total of 148 patients will be enrolled and the duration of the study will be 5 years All patients will be required to follow-up at 2-week 6-week 3-month 6-month 1-year and 2-year post-operative marks Any time information is collected for a study there is a small risk of breach of confidentiality There are no monetary costs or payments associated with this study You may or may not benefit by taking part in this study There is no guarantee that you will receive direct benefit from your participation in this study To be clear participation in this study is completely voluntary
Detailed Description:
Youre going to undergo a procedure called a reverse shoulder replacement and Im sure Dr Gilotra already went over the procedure with you but I will again briefly Before the hardware is put in there is a tendon in your shoulder that has to be released Its released because the doctor has to move it out of the way to get to your shoulder joint Now when the hardware has been implanted and the surgery is complete the doctor now has two options He can decide to repair this tendon or not The thing is due to the hardware that is implanted your shoulder doesnt really need this tendon anymore to help it move So there are some doctors in the country who choose to repair the tendon and there are some doctors who choose to just let it be Patients have done great with either or
We are performing this nationwide study to see if one option between repairing this tendon or leaving it is slightly better than the other There is a chance that repairing the tendon can decrease the risk of dislocations in the future and also help you move your arm better There is a chance that this repair doesnt matter at all If we figure out whether to repair or not to repair this tendon we will be able to better define complications potentially decrease surgery time and improve how well patients perform daily activities
We randomize you to the repair on dont repair group almost like flipping a coin With me youll be answering simple questions that will track your functionality over time
We are performing this nationwide study to see if one option between repairing this tendon or leaving it is slightly better than the other There is a chance that repairing the tendon can decrease the risk of dislocations in the future and also help you move your arm better There is a chance that this repair doesnt matter at all If we figure out whether to repair or not to repair this tendon we will be able to better define complications potentially decrease surgery time and improve how well patients perform daily activities
We randomize you to the repair on dont repair group almost like flipping a coin With me youll be answering simple questions that will track your functionality over time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None