Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588506
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2020-10-08
Brief Title:
Tendon Transfer Rotator Cuff Tear
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Tendon Transfer Techniques for Massive Rotator Cuff Tear Repairs An Integrated Prospective Randomized Multicenter Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This is a prospective randomized study on using muscle tendons to repair tears of the muscles on the shoulder There are 3 muscles covering the shoulder joint- supraspinatus infraspinatus and subscapularis Large tears involving these muscles can be treated by using some muscle from another location of the body known as Tendon transfer techniques These muscle tendons may be from the lower back Latissimus Dorsi upper pack lower trapezius or chest pectoralis There are currently no studies to show which tendon transfer technique has better outcomes
This study comprises two trials and a total of 84 participants would be enrolled Each trial comparing the patient reported outcomes between two tendon transfer techniques Large tears involving the supraspinatus and infraspinatus would be repaired using either the Latissimus dorsi technique or Lower trapezius technique 21 patients would be randomly assigned to either groups The second trial would be comparing the Latissimus dorsi technique and pectoralis technique in large tears of the subscapularis muscle Another 21 patients would be randomly assigned to either groups
The investigators are studying to see if the Lower Trapezius and Pectoralis transfer techniques for muscle tear repairs would have better post-surgical outcomes compared with Latissimus Dorsi transfer technique
For both trials participants would be followed up for 2 years and post-surgical outcomes would be compared between treatment groups
This study comprises two trials and a total of 84 participants would be enrolled Each trial comparing the patient reported outcomes between two tendon transfer techniques Large tears involving the supraspinatus and infraspinatus would be repaired using either the Latissimus dorsi technique or Lower trapezius technique 21 patients would be randomly assigned to either groups The second trial would be comparing the Latissimus dorsi technique and pectoralis technique in large tears of the subscapularis muscle Another 21 patients would be randomly assigned to either groups
The investigators are studying to see if the Lower Trapezius and Pectoralis transfer techniques for muscle tear repairs would have better post-surgical outcomes compared with Latissimus Dorsi transfer technique
For both trials participants would be followed up for 2 years and post-surgical outcomes would be compared between treatment groups
Detailed Description:
None
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