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
Inclusion Criteria5
- Patients requiring surgical rotator cuff treatment of a partial- or small full-thickness tear of the supraspinatus tendon, as determined jointly by the surgeon and the patient.
- Patients with chronic shoulder pain lasting longer than three months and resistant to pain medication and conservative treatment.
- Patients over 40 years and under 65 years of age at time of surgery.
- Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up and rehabilitation.
- Patients who are capable of, and have given informed consent to their participation in the study.
Exclusion Criteria14
- Patients with instability of the index shoulder.
- Patients with grade 3 or greater chondromalacia of the index shoulder.
- Patients who require concomitant procedures other than acromioplasty/subacromial decompression, acromioclavicular joint resection, or biceps tenotomy/tenodesis at least 2 cm distal to the site of supraspinatus tendon treatment.
- Patients with evidence of calcification of the rotator cuff of the index shoulder.
- Patients with evidence of grade 2 fatty infiltration or greater of the supraspinatus muscle of the index shoulder on a sagittal view of an MRI scan.
- Patients with insulin dependent diabetes or other autoimmune or immune deficiency disorders.
- Patients with genetic collagen disease.
- Patients with chronic inflammatory disease.
- Pregnant women or those seeking to become pregnant.
- Patients who have had previous rotator cuff shoulder surgery on the index shoulder.
- Patients with a history of oral steroid use in the last 2 months or injectable steroid use in the last 4 weeks.
- Patients with an inability to complete post-surgery physical therapy or return for follow-up visits.
- Patients who have been heavy smokers within the last 6 months (more than 20 cigarettes per day).
- Patients with a known history of hypersensitivity to bovine-derived materials.
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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