Post-Market Evaluation of the Rotation Medical Rotator Cuff System

Primary Outcomes (4)

• Change in Tendon Thickness

  The total thickness of the tendon and any newly induced tissue at the implant site were measured at 3 months, 1 year, and 2 years using magnetic resonance imaging (MRI). Measurements were compared to pre-operative (baseline) supraspinatus tendon thickness to calculate the mean (± SD) change in post-operative supraspinatus tendon thickness by partial-thickness tear size (Intermediate or High) or full thickness tear size (Medium or Large).

  Pre-operatively (baseline) to 3 month, 1 year, and 2 year

• Integration of Induced Tissue With Underlying Tendon

  Partial-thickness tears were classified as Intermediate (3-6 mm) or High (\> 6 mm) grade tears. Full thickness tears were categorized using Cofield classification as Medium (1-3 cm) or Large (3-5 cm). Integration and maturation of the newly induced tissue was assessed by MRI at each post-operative follow-up and determined by answering Yes, No, or Unable to determine to the following questions: 1. Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? 2. Is there visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? 3. Was there evidence of bursitis in the shoulder? 4. Does the new tissue resemble normal tendon tissue? 5. Does the underlying tendon resemble normal tendon tissue? 6. Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?

  3 months, 1 year, and 2 years

• Fill-In of Partial Thickness Tears and Underlying Tendon Quality

  For tendon defects treated by standalone use of the device (i.e., implantation without surgical repair using sutures/suture anchors), post-operative follow-up MRIs will be used to estimate the amount of defect fill-in with newly induced tissue and the quality of the filled-in tissue. In the absence of fill-in with newly induced tissue, defect progression (i.e., change in size relative to previous MRIs) will be assessed. The amount of fill-in relative to the pre-operative, baseline MRI classified as: * 0 to \<25% * 25% to \<50% * 50% to \< 75% * 75% to \< 100% * 100%