None listed
Conditions
Brief 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.
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 an
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.
Sponsors
Rotation Medical, Inc.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
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.
Outcome results
None listed