Rotator cuff repair (RCR) is a common first-line surgical solution to symptomatic rotator cuff injury, with over 270,000 RCRs performed annually, and growing at a rate of 141%. Unfortunately, 30-94% of the cases are complicated by failure and re-tear of the repaired tendon, which commonly results in a significant reduction in activities of daily living, work, and/or sports and recreation for the patient due to pain and restricted movement. Failed rotator cuff repairs stem from issues associated with suture retention, maintaining the correct anatomic position of the tendon when reattached, and the lack of enduring mechanical support for the shoulder and repaired tendon, which is necessary to allow adequate healing time after the surgical procedure. These issues are even more problematic for severe or chronic tears where muscle atrophy, fatty infiltration, and retraction from the anatomic insertion site complicate tendon repairs. In this project, we propose a high-performance textile-based implant designed to address the deficiencies of current RCR. The innovation of the project is two- fold: (1) the scaffold is designed to mimic the mechanical properties of native tendon and (2) the partially resorbable structure and the specific utilization of resorbable and non-resorbable yarns minimizes the potential generation of particulate debris, maintains discrete, interconnected zones to promote cell infiltration, differentiation, and integration with both the tendon and bone tissues in their respective zones. We aim to further the development of this high-performance scaffold by varying weaving parameters in order to maximize the biological properties, while retaining the mechanical properties of native tendon. In Aim 1, fiber diameter and yarn spacing will be modulated to create implants with different architectures in four combinations that will be studied in vitro via explant culture, and assessed via histological and biomechanical analysis. In Aim 2, the optimized scaffold will be assessed in an clinically relevant ovine model of chronic tendinopathy, which we have shown to mimic the chronic human condition. Additionally, by attaching the implant to a completely transected tendon, this model also tests the efficacy of the implant under a severe clinical condition of a complete mechanical deficit. The control cohort will be repaired using advanced suture techniques only, which is the current standard of care. At 6 months, mobility restoration, tendon and bone integration, and repair strength will be assessed via biomechanical testing and histological analysis. The goal of this study is to further the development of a new implant specifically tailored to meet the disparate requirements for both tendon and bone incorporation during repair of severely torn rotator cuff tendons. We anticipate that this will lead to improved functionality of the injured cuff in these challenging cases and ultimately improve long-term clinical outcomes.
Public Health Relevance Statement: NARRATIVE Rotator cuff repairs suffer from high failure rates due to tendon re-tear despite many advances in surgical procedures. To address this problem, particularly for severe and clinically challenging cases, we propose a high performance, textile-based implant that provides mechanical support while promoting healing and integration with native tissues. The ultimate objective of this project is to refine the properties of the device and then to assess its potential for improving rotator cuff repair in a clinically relevant chronic tendiopathy animal model.
Project Terms: 3-Dimensional; Activities of Daily Living; Address; Affect; Anatomy; Animal Model; Architecture; base; Beds; Biological; biomaterial compatibility; Biomechanics; bone; Bone Tissue; Caliber; caprolactone; Cells; Cellular Infiltration; Chronic; Chronic Disease; Clinical; clinically relevant; cohort; Control Groups; design; Development; Devices; Disease model; efficacy testing; Engineering; Failure; Fiber; Generations; Goals; Greater Tuberosity; healing; Histologic; Human; Hybrids; Implant; implant design; improved; improved functioning; In Vitro; Infiltration; infraspinatous muscle; injured; innovation; Intellectual Property; Joints; Lateral; Link; mechanical properties; Mechanics; Methods; Modeling; Movement; Muscular Atrophy; novel; Operative Surgical Procedures; Outcome; Outcome Measure; Pain; Particulate; Patients; Performance; phase 2 study; Polymers; Positioning Attribute; prevent; Procedures; Property; Psychological reinforcement; Recreation; regenerative; repaired; restoration; Rotator Cuff; rotator cuff injury; rotator cuff tear; scaffold; Shoulder; Site; Sports; standard of care; stem; Structure; substantia spongiosa; success; Surgical sutures; Suture Techniques; Technology; Tendinopathy; Tendon structure; Testing; Textiles; Thick; Time; Tissue Engineering; tissue support frame; Tissues; ultra-high molecular weight polyethylene; Work
