To determine the effectiveness of human dehydrated umbilical cord allograft in standard open rotator cuff repair as assessed by the American Shoulder and Elbow Surgeons (ASES) score 12 months post-op.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
human dehydrated umbilical cord allograft
Open rotator cuff surgery with standard suture repair
Hand & UpperEx Center
Wexford, Pennsylvania, United States
ASES score
The primary endpoint of the study is the number of subjects achieving a 20% increase from baseline in the overall ASES score at 12 months post-op.
Time frame: 12 months
Constant Murley Score
Comparison of Constant scores between the two groups at each study time point
Time frame: 12 months
Shoulder range of motion
Assessment of the change in the range of motion of the shoulder joint for both treatment groups at each study time point.
Time frame: 12 months
VAS Pain scores
Change in patient reported pain from baseline
Time frame: 12 months
Incidence of tendon re-tear
Incidence of supraspinatus tendon re-tear in the two treatment groups as assessed by review of MRI scans by independent radiologists
Time frame: 12 months
Incidence of adverse events
Incidence of adverse events
Time frame: 12 months
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