Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-25 @ 2:34 PM
NCT ID:
NCT02484950
Group ID:
EG000
Title:
Rotator Cuff Repair With Stem Cells
Description:
Using clinically accepted methods, subjects will undergo bone marrow aspiration (from hip, proximal humerus or tibia) through a small incision prior to arthroscopy in the group undergoing MSC augmentation. They will then undergo arthroscopic full thickness rotator cuff repair using a double row, TOE anchor/suture technique with mesenchymal stem cell augmentation.
Mesenchymal stem cell augmentation in rotator cuff repair: Patients undergoing mesenchymal stem cell augmentation will receive a total injection of 6 milliliters (mL). Of this, 3 mL will be injected in the tendon at the junction between bone and tendon, while 3 mL will be injected in the bone at the site of the surgical footprint.
Standard arthroscopic rotator cuff repair: All patients will undergo full thickness rotator cuff repair using a double row, transosseous-equivalent (TOE) repair with anchor/suture technique. Acromioplasty will be performed in all patients. Alternate procedures such as biceps tenotomy/tenodesis and distal clavicle excision will be performed at the discretion of the surgeon and recorded.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
28
Other Number Affected:
0
Other Number At Risk:
28
Study:
NCT02484950
Results Section:
NCT02484950
Adverse Events Module:
NCT02484950