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 percent re-operation rate at six months, and 100 percent 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 percent 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 orthopedic surgeon, Dr. Peter Kurzweil, Memorial Orthopaedic Surgical Group commented, "The STITCH Study is a ground-breaking endeavor. To date, many orthopedic 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.
1 Metcalf MH, Barrett GR. Prospective Evaluation of 1485 Meniscal Tear Patterns in Patients with Stable Knees. AJSM. 2004;32(3):675-680
2 Saliman JD. Circumferential Compression Stitch for Meniscus Repair. Arthroscopy Tech. 2013;2(3):257-264
3 Beamer et al. Changes in Contact Area in Meniscus Horizontal Cleavage Tears Subjected to Repair and Resection. JARS.2017;33(3):617-624
4 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
5 2018 SmartTRAK US Meniscal Repair Fixation market report