Smith & Nephew meniscal knee repair technology delivers 0% re-operation rate and 100% meniscal healing at six months shows first ever study of horizontal cleavage tears
LONDON, July 11, 2019 /PRNewswire/ -- Smith & Nephew (NYSE: SNN; LSE: SN), the global medical technology business, today announces the results of the first ever prospective clinical trial to evaluate the effectiveness of repairing Horizontal Cleavage Tears (HCTs), one of the most common meniscal tears affecting approximately one-third of patients with this injury.1 The STITCH Study is examining the effectiveness of repair using Smith & Nephew's NOVOSTITCH™ Meniscal Repair System, available only in the US, which addresses complex meniscal tear patterns not adequately served by other repair systems, including HCTs.
STITCH enrolled thirty patients with meniscal tears at eight sites across the US. Three endpoints were examined:
- Meniscal healing upon second look needle arthroscopy,
- Freedom from re-operation, and
- Improvements in knee pain and function as measured by Patient Reported Outcomes (PROs) including KOOS, IKDC, Lysholm and Tenger scores.
Six-month results across all three endpoints reported significant improvement in all PROs, including a 0% re-operation rate at six months, and 100% meniscal healing upon second look arthroscopy as measured by no visible defect during in-office, needle endoscopy.
"These initial STITCH results demonstrating successful HCT repair are very promising. This is exciting to see, as many patients are affected by these types of meniscal tears, which have previously been considered irreparable,"1,2 said Dr. David Flanigan, director of the cartilage restoration program at The Ohio State University Wexner Medical Center and co-author of STITCH.
Historically, HCTs were treated conservatively or by partial resection, commonly referred to as a meniscectomy, which may put the patient at risk for adverse changes to the knee joint, leaving them open to osteoarthritis or total knee replacement later in life. 3,4 NOVOSTITCH is highly complementary to Smith & Nephew's leading FAST-FIX™ 360 Meniscal Repair System, which addresses vertical tears, the most commonly repaired meniscal injury today.
"There are currently more than 1.2 million meniscal tears treated surgically in the US each year with only 15-20% of the cases receiving a meniscal repair, rather than removal,"5 stated Brad Cannon, President of Global Sports Medicine and ENT at Smith & Nephew. "With products like NOVOSTITCH PRO and FAST-FIX 360 we see the opportunity to double this proportion in the medium term."
The NOVOSTITCH device is designed for access and safety in tight knee joints and offers surgeons the potential to place circumferential compression stitches in locations previously not possible, thereby potentially expanding the meniscal repair option for many patients.2
Study Principal Investigator and internationally recognized orthopaedic surgeon, Dr. Peter Kurzweil, Memorial Orthopaedic Surgical Group commented, "The STITCH Study is a ground-breaking endeavor. To date, many orthopaedic surgeons still hold questions regarding the effectiveness of meniscal repair, and this initial data from our study endpoints are vastly encouraging. I'm looking forward to our future results." The STITCH Study will continue to follow patients for two years post-operation.
The six-month STITCH results were recently presented at the International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS), Cancun, MX in May 2019.
To learn more about the NOVOSTITCH™ PRO please visit: http://www.AllTearsAllRepairs.com
About Smith & Nephew
Smith & Nephew is a portfolio medical technology business that exists to restore people's bodies, and their self-belief. Smith & Nephew has leadership positions in Orthopaedics, Advanced Wound Management and Sports Medicine, more than 16,000 employees and a presence in more than 100 countries. Annual sales in 2018 were $4.9 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN). For more information about Smith & Nephew, please visit our corporate website www.smith-nephew.com and follow us on Twitter, LinkedIn or Facebook.
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith& Nephew's most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew's expectations.
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- Metcalf MH, Barrett GR. Prospective Evaluation of 1485 Meniscal Tear Patterns in Patients with Stable Knees. AJSM. 2004;32(3):675-680
- Saliman JD. Circumferential Compression Stitch for Meniscus Repair. Arthroscopy Tech. 2013;2(3):257-264
- 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
- 2018 SmartTRAK US Meniscal Repair Fixation market report
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