Global Compressive Loading from an Ultra-Thin PEEK Button Augment Enhances Fibrocartilage Regeneration of Rotator Cuff Enthesis.

A PEEK button is developed to improve the tendon-to-bone compression area. In total, 18 goats were divided into 12-week, 4-week, and 0-week groups. All underwent bilateral detachment of the infraspinatus tendon. In the 12-week group, 6 were fixed with a 0.8-1 mm-thick PEEK augment (A-12, Augmented), and 6 were fixed with the double-row technique (DR-12). Overall, 6 infraspinatus were fixed with PEEK augment (A-4) and without PEEK augment (DR-4) in the 4-week group. The same condition was performed in the 0-week groups (A-0 and DR-0). Mechanical testing, immunohistochemistry assessment, cell responses, tissue alternation, surgical impact, remodeling, and the expression of type I, II, and III collagen of the native tendon-to-bone insertion and new footprint areas were evaluated. The average maximum load in the A-12 group (393.75 (84.40) N) was significantly larger than in the TOE-12 group (229.17 (43.94) N) ( < 0.001). Cell responses and tissue alternations in the 4-week group were slight. The new footprint area of the A-4 group had better fibrocartilage maturation and more type III collagen expression than in DR-4 group. This result proved the novel device is safe and provides superior load-displacement to the double-row technique. There is a trend toward better fibrocartilage maturation and more collagen III secretions in the PEEK augmentation group.