Suture anchors provide a quick, secure, and simple means of surgically attaching soft tissue to bone. Since their introduction in 1985, suture anchors have been widely used in a variety of surgical procedures. They provide a significant savings in time and cost to both surgeon and patient. However, there are a number of shortcomings with current anchors. Existing suture anchors perform poorly in osteoporotic bone and cannot be repositioned easily following implantation. The issue of attachment to osteoporotic bone will become increasingly important with a growing active adult population. We propose the development of a novel, new suture anchor technology that possesses the same benefits of existing devices but yields significant advantages. The new anchor is less invasive, can be readily repositioned, provides exceptional performance in poor quality bone, and can be used as a revision device for other anchors. Based on the Phase I confirmation of feasibility, the goal of the Phase II work is the specific product development of the rotator cuff repair anchor, followed by design modification for a diverse product line of anchor products. Rotator cuff repair is a high volume surgical operation that often involves poor quality bone in the proximal humerus where standard anchor devices do not provide adequate fixation strength. The development of this anchor and associated insertion tooling will utilize a finite element analysis design tool. A thorough bench testing regimen will be performed to establish regulatory equivalence to a commercial predicate device, with a special focus on fixation strength in an osteoporotic bone model. A group of shoulder specialists will assess the utility of the anchor system by performing simulated cuff repairs in a cadaveric model. Rotator cuff reconstructions using the prototype systems and current devices will also be tested in a dynamic shoulder testing system to evaluate the cyclic failure risk of early rehabilitation protocols. Many references in the literature that indicate that early, aggressive rehabilitation regimens may cause a significant decrease in anchor fixation strength, laxity in the cuff reconstruction, and even the elevated failure rate of the operation. A review panel of surgeons in a diverse range of specialties will contribute specifications in the development process and critically review the system design and final project results. ? ?
