_____________________________________________________________________________________ Literature and Registry Review 2005 - 2015 ______________________________________________________________________ “HEMICAP RESURFACING PROVIDES A UNIQUE AND FAVORABLE ALTERNATIVE TO PRIOR IMPLANT DESIGNS BY PROVIDING ANATOMIC RE-APPROXIMATION” Patellofemoral Kinematics After Limited Resurfacing of the Trochlea. Provencher M, Ghodadra N, Verma N, Cole BJ, Zaire S, Shewman E, Bach B. J Knee Surg. 2009;22:310-316 ______________________________________________________________________ Matthias R. Schurhoff _____________________________________________________________________________________ Arthrosurface Literature and Registry Review 2005-2015 _____________________________________________________________________________________________ Foreword his report is a review of the past decade outlining the introduction of inlay arthroplasty for arthrosis, early T arthritis and traumatic lesions. Arthrosurface, Inc. (Franklin, MA) was launched in 2002 bringing innovation and a sports medicine approach to primary arthroplasty. In the past decade, Arthrosurface has invested and re-invested more than $100 Million dollars in the development and commercialization of patient specific joint solutions that place the individual patient at the forefront of clinical decision making. The intraoperative choice of implant diameters and contour shapes allow the surgeon to not only cover the defect effectively, but also fit the implant to the patient while preserving healthy bone and cartilage. This is a departure from traditional arthroplasty, where the patient is typically fitted to the implant using large bone cuts, cement and artificial joint replacements. In contrast, Arthrosurface inlay arthroplasty is anatomically grouped with many curvatures within each diameter ensuring an off-the-shelf custom implant fit. The anatomic match is achieved using intraoperative visualization and 3D mapping of the joint surface. The range of implants can accommodate surface pathologies from focal to total arthroplasty thereby extending joint preservation therapy into the future. Over time, the implant portfolio continued to expand and now incorporates more than 170 implant sizes and curves for treatment of shoulder, hip, knee, ankle, and forefoot defects. Patient demands continue towards “active solutions” with quick pain relief and fast re-integration into work and sports. New biological therapies and novel implant designs have been introduced to meet this ongoing trend and relegate traditional arthroplasty into late stage solutions to accommodate today’s lifespan longevity. Joint restoration and preservation have become critical considerations for the long term treatment of joint arthrosis and arthritis. The transition into arthroplasty with inlay technology as a primary solution provides inherent advantages for high functional demands and future treatment options. _____________________________________________________________________________________ Page 2 of 195 Arthrosurface Literature and Registry Review 2005-2015 _____________________________________________________________________________________________ In 2013, Arthrosurface entered into biological cartilage therapies with an innovation of the 20 year old microfracture technique: The introduction of Nanofracture® was designed to address the shortfalls inherent to microfracture: Lack of a standardized technique, shallow perforation depth, subchondral bone disruption and tunnel compaction. New frontiers in cartilage repair and tissue augmentation are now being explored with “nanofracture plus” where the standardized and improved marrow stimulation design is combined with biological therapies including scaffolds, growth factors and stem cells. The human element of science, technology, and innovation is frequently lost among standardized testing and averaged reporting methods. Therefore it is noteworthy to highlight individual success stories from patients who returned to remarkable performance levels winning championships in a variety of sporting disciplines following their Arthrosurface procedure. A few of these patients are featured in this review with their permission. Many authors have reported, discussed, assessed, or mentioned Arthrosurface solutions in the primary and secondary literature. The selection of quotes from these articles inherently includes bias; however the collective opinion from experienced surgeons and thought leaders in the field of joint restoration lends itself as an educational tool for future research and scientific dialogue. The goal of this assessment is to provide a comprehensive overview on the current knowledgebase, describe the technology from various angles, outline the growing range of indications, and profile key advantages that are unique to Arthrosurface procedures. Matthias R. Schurhoff, M.D. Vice President of Clinical Operations and Scientific Affairs Arthrosurface, Inc. 28 Forge Parkway Franklin, MA 02038 March, 2015 _____________________________________________________________________________________ Page 3 of 195 Arthrosurface Literature and Registry Review 2005-2015 _____________________________________________________________________________________________ Arthrosurface Joint Restoration From Biology to Arthroplasty _____________________________________________________________________________________ Page 4 of 195 Arthrosurface Literature and Registry Review 2005-2015 _____________________________________________________________________________________________ Table of Contents Foreword ...................................................................................................... 2 I. Overview ................................................................................................... 6 II. Shoulder ................................................................................................... 7 1. Shoulder Registry Review ..................................................................................................... 8 2. Shoulder Publication Summaries ........................................................................................ 11 Basic Science ...................................................................................................................... 11 Clinical Science ................................................................................................................... 16 3. Shoulder References .......................................................................................................... 71 III. Knee ...................................................................................................... 75 1. Knee Publication Summaries .............................................................................................. 76 Basic Science ...................................................................................................................... 76 Clinical Science ................................................................................................................... 84 2. Knee References .............................................................................................................. 120 IV. Foot & Ankle ....................................................................................... 123 A. Ankle ................................................................................................................................. 124 1. Ankle Publication Summaries ............................................................................................ 125 Basic Science .................................................................................................................... 125 Clinical Science ................................................................................................................. 130 B. Forefoot ............................................................................................................................. 150 1. Forefoot Publication Summaries ....................................................................................... 151 Clinical Science ................................................................................................................. 151 2. Forefoot References .......................................................................................................... 183 V. Hip ....................................................................................................... 185 1. Hip Publication Summaries ............................................................................................... 186 Clinical Science ................................................................................................................. 186 2. Hip References .................................................................................................................. 194 _____________________________________________________________________________________ Page 5 of 195 Arthrosurface Literature and Registry Review 2005-2015 _____________________________________________________________________________________________ I. Overview The primary and secondary literature has been very supportive describing innovative clinical pathways based on Arthrosurface technology. 73% (105) of these publications had a positive and supportive assessment or conclusion, 23% (32) had a noteworthy inclusion in the publication but refrained from further validation mostly due to pending evidence in