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Full Thickness Rotator Cuff Tear clinical trials

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NCT ID: NCT01256242 Completed - Clinical trials for Full Thickness Rotator Cuff Tear

Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears

Start date: November 24, 2010
Phase: N/A
Study type: Interventional

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.