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.
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References
- 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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