RecruitingACTRN12611001082998

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.


Sponsor

Rotation Medical, Inc.

Enrollment

36 participants

Start Date

Nov 1, 2011

Study Type

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

Sex: Both males and femalesMin Age: 40 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether placing a thin collagen scaffold (a supportive patch made from natural material) during shoulder surgery helps to thicken and repair a damaged rotator cuff tendon better than surgery alone. The rotator cuff is a group of tendons that holds the shoulder together. Partial tears are common and can cause ongoing pain. MRI scans will be used to measure tendon thickness before and after surgery. You may be eligible if: - You are between 40 and 65 years old - You have chronic shoulder pain lasting more than 3 months - Your pain has not improved with medications or other treatments - You need surgery for a partial or small full-thickness tear of your shoulder tendon You may NOT be eligible if: - You have shoulder instability or significant cartilage damage - You have previously had rotator cuff surgery on the same shoulder - You have diabetes requiring insulin, an autoimmune disorder, or an immune deficiency - You are pregnant or planning to become pregnant - You are a heavy smoker (more than 20 cigarettes per day) - You have a known allergy to bovine (cow-derived) materials Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Australia

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ACTRN12611001082998