Scaffold Implant for Rotator Cuff Lesions Encountered on the Supraspinatus Tendon
Study to determine if the addition of a collagen scaffold device will increase tendon thickness with comparable clinical outcomes over subacromial decompression and/or repair alone in patients with a supraspinatus tear.
Rotation Medical, Inc.
36 participants
Nov 1, 2011
Interventional
Conditions
Summary
The study hypothesis is that the addition of a surgically implanted collagen scaffold will structurally thicken the tendon, measured with MRI, compared with tendons that are treated with standard decompression and/or repair alone without the scaffold.
Eligibility
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Interventions
Arm 1 – Partial thickness tears surgically treated with the addition of an implanted collagen scaffold Arm 2 – Partial thickness tears surgically treated without the addition of an implanted collagen scaffold; standard subacromial decompression and/or repair alone (control) Arm 3 – Larger partial thickness tears or small full thickness tears surgically treated with the addition of an implanted collagen scaffold The surgical placement of the collagen scaffold following standard decompression and/or repair in treatment Arms 1 and 3 is expected to add approximately 20 minutes to the standard rotator cuff tear procedure in Arm 2 (control), which takes approximately 40 to 90 minutes depending on the size and complexity of the tear.
Locations(1)
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ACTRN12611001082998