LONDON, Nov. 17, 2020 /PRNewswire/ -- Smith+Nephew (LSE:SN,NYSE:SNN), the global medical technology business, is pleased to announce the conclusion of and successful two-year follow-up results from the STITCH Study for its novel NOVOSTITCH Meniscal Repair Systems. The two-year results make a compelling case for surgeons to consider repairing the meniscus versus removing it.
The STITCH Study is the first of its kind, prospective clinical trial to evaluate the effectiveness of repairing Horizontal Cleavage Tears (HCTs), one of the most common meniscal tears.2 Of the 1.2 million tears that occur annually in the US, nearly 80% are treated by partial resection,3,4 also known as meniscectomy, which may put the patient at risk for adverse changes to the knee joint by leaving them open to osteoarthritis or total knee replacement later in life.5, 6
The two-year results of the study demonstrated:
- A clinical success rate of 82.6%7
- Statistically significant improvements in all Patient Reported Outcome Measures (PROMs) from baseline to two years (p<0.001)7
- Complete meniscal healing (no visible defect) in 100% of patients undergoing needle arthroscopy at six months (11/11)7
"These results from the STITCH study set a new standard for outcomes in meniscal repair," said Dr. David Flanigan, Director of the Cartilage Restoration Program at The Ohio State University Wexner Medical Center and co-author of the STITCH Study. "Over two years of follow-up, the NOVOSTITCH Meniscal Repair System now presents an opportunity for a paradigm shift in the treatment of meniscal tears from meniscectomy to repair," Flanigan further commented.
Smith+Nephew's NOVOSTITCH Meniscal Repair System addresses challenging meniscal tear patterns not adequately served by other repair systems. By enabling surgeons to place stitches arthroscopically in tight joint compartments, NOVOSTITCH utilizes an all-inside, all-suture meniscus-to-meniscus circumferential compression stitch allowing repair of challenging meniscal tears. The system includes an ergonomic handle design, well-defined visual cues for precise stitch placement, and control and stability for accurate suture placement.
STITCH Study Principal Investigator and orthopaedic surgeon, Dr. Peter Kurzweil, Memorial Orthopaedic Surgical Group, commented, "I'm gratified by the final results of the STITCH study. Two-year data is compelling and indicate that HCT's can and should be repaired when possible. The NOVOSTITCH™ Meniscal Repair System is now proven to be an effective tool capable of expanding meniscal repair for tears that have been considered irreparable, up until now."
"The STITCH Study represents a landmark achievement for Smith+Nephew by defining our commitment to drive the science behind meniscal repair and elevate the standard of care," stated Scott Schaffner, SVP of Global Marketing and US Commercial, Sports Medicine at Smith+Nephew. "Our goal is to get surgeons to think repair first – not removal."
The NOVOSTITCH™ PRO Meniscal Repair System - available in the US, Europe and other select countries - complements Smith+Nephew's leading All Tears, All Repairs meniscal repair portfolio. To learn more about the portfolio and the NOVOSTITCH PRO Meniscal Repair System please visit: http://www.AllTearsAllRepairs.com
- Kurzweil PR, Lynch, NM, Coleman S, Kearney B. Repair of Horizontal Meniscus Tears: A Systematic Review. Arthroscopy. 2014;30(11):1513-1519
- Metcalf MH, Barrett GR. Prospective Evaluation of 1485 Meniscal Tear Patterns in Patients with Stable Knees. AJSM. 2004;32(3):675-680
- Abrams GD, Frank RM, Gupta AK, Harris JD, McCormick FM, Cole BJ. Trends in Meniscus Repair and Meniscectomy in the United States, 2005-2011
- 2018 SmartTRAK US Meniscal Repair Fixation market report
- Beamer et al. Changes in Contact Area in Meniscus Horizontal Cleavage Tears Subjected to Repair and Resection. JARS.2017;33(3):617-624
- Papalia R, Del Buono A, Osti L, Denaro V, Maffulli N. Meniscectomy as a risk factor for knee osteoarthritis: a systematic review. British Medical Bulletin 2011;99:89-106
- STITCH two year clinical study report: Kurzweil P, et al. (2020)
Smith+Nephew is a portfolio medical technology business that exists to restore people's bodies and their self-belief by using technology to take the limits off living. We call this purpose 'Life Unlimited'. Our 16,000+ employees deliver this mission every day, making a difference to patients' lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global franchises of Orthopaedics, Advanced Wound Management and Sports Medicine & ENT. Founded in Hull, UK, in 1856, we now operate in more than 100 countries, and generated annual sales of $4.9 billion in 2018. Smith+Nephew is a constituent of the FTSE100 (LSE:SN,NYSE:SNN). The terms 'Group' and 'Smith+Nephew' are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context requires otherwise.
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