Full Thickness Rotator Cuff Tear Clinical Trial
Official title:
A Single Blinded, Multi-center, Randomized, Controlled, Pilot Study to Evaluate the Safety and Performance of Augmentâ„¢ Rotator Cuff for Primary Surgical Treatment of Full Thickness Rotator Cuff Tears
Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary
surgical treatment for full thickness rotator cuff tears. The hypothesis is that Augment
Rotator Cuff will be easy to deliver as an inter-positional graft placed between the rotator
cuff tendon and the humeral head providing further enhanced tendon to bone healing without
adding any additional safety risk to the patient.
Study Rationale: To evaluate the safety and performance Augmentâ„¢ Rotator Cuff in surgical
intervention of a torn rotator cuff and to obtain preliminary data to support the rationale
for a subsequent pivotal clinical trial.
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