Augmentation Devices for Rotator Cuff Repair

Rotator cuff tears affect 40% or more of those over age 60 and are a common cause of pain and disability. Surgical repairs have high failure rates that range from 20 to 90%. Currently, scaffolds derived from various natural and synthetic biomaterials are being marketed as augmentation devices for rotator cuff repairs at the time of surgery ^1–3. The US Food and Drug Administration (FDA) has cleared these devices “to support soft tissues where weakness exists” but not “to provide the full mechanical strength for the tendon repair”. Based on the mechanical connotation of their intended use, it is commonly believed that when applied appropriately, these devices may provide some degree of load sharing of forces across the tendon repair site and thus decrease the likelihood of tendon re-tear.