PR Newswire10.10.19
Smith+Nephew announced results for its NOVOSTITCH Meniscal Repair System at the International Cartilage Regeneration & Joint Preservation Society (ICRS), Vancouver, Canada highlighting one-year results of the STITCH Study.
The STITCH Study is the first 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 results of the study demonstrated:
Smith+Nephew's NOVOSTITCH Meniscal Repair System addresses complex meniscal tear patterns not adequately served by other repair systems. Typically, HCTs are 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.2,3 Historically, in studies of HCT repair over a follow-up period ranging from 11-70 months, the success rate averaged approximately 78 percent.4
"As more surgeons choose to repair versus resect the meniscus, these positive data points help expand this option to more patients with tears previously considered irreparable."4,5 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.
"Smith+Nephew's goal is to transform the surgical paradigm by elevating the standard of care for meniscal tears to a repair instead of a meniscectomy where appropriate," stated Brad Cannon, President of Global Sports Medicine and ENT at Smith+Nephew. "Currently more than 1.2 million meniscal tears are treated surgically in the US each year with only 15-20 percent of the cases receiving a repair rather than removal.6 This needs to change," Cannon remarked.
STITCH Study Principal Investigator and orthopaedic surgeon, Dr. Peter Kurzweil, Memorial Orthopaedic Surgical Group, commented, "The one-year results from STITCH are compelling as the data challenges the notion that HCTs have an unacceptably low rate of repair success when in fact, they have comparable success rates to those of other meniscal tears."
The STITCH Study will continue to follow patients for two years post-operatively.
References
1 Metcalf MH, Barrett GR. Prospective Evaluation of 1485 Meniscal Tear Patterns in Patients with Stable Knees. AJSM. 2004;32(3):675-680
2 Beamer et al. Changes in Contact Area in Meniscus Horizontal Cleavage Tears Subjected to Repair and Resection. JARS.2017;33(3):617-624
3 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
4 Kurzweil PR, Lynch, NM, Coleman S, Kearney B. Repair of Horizontal Meniscus Tears: A Systematic Review. Arthroscopy. 2014;30(11):1513-1519
5 Abrams GD, Frank RM, Gupta AK, Harris JD, McCormick FM, Cole BJ. Trends in Meniscus Repair and Meniscectomy in the United States, 2005-2011
6 2018 SmartTRAK US Meniscal Repair Fixation market report
The STITCH Study is the first 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 results of the study demonstrated:
- A success rate of 91.7 percent (reoperation rate of only 8.3 percent), and
- A significant improvement in knee pain and function in all Patient Reported Outcomes (PROs) including KOOS, IKDC, Lysholm and Tegner scores.
Smith+Nephew's NOVOSTITCH Meniscal Repair System addresses complex meniscal tear patterns not adequately served by other repair systems. Typically, HCTs are 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.2,3 Historically, in studies of HCT repair over a follow-up period ranging from 11-70 months, the success rate averaged approximately 78 percent.4
"As more surgeons choose to repair versus resect the meniscus, these positive data points help expand this option to more patients with tears previously considered irreparable."4,5 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.
"Smith+Nephew's goal is to transform the surgical paradigm by elevating the standard of care for meniscal tears to a repair instead of a meniscectomy where appropriate," stated Brad Cannon, President of Global Sports Medicine and ENT at Smith+Nephew. "Currently more than 1.2 million meniscal tears are treated surgically in the US each year with only 15-20 percent of the cases receiving a repair rather than removal.6 This needs to change," Cannon remarked.
STITCH Study Principal Investigator and orthopaedic surgeon, Dr. Peter Kurzweil, Memorial Orthopaedic Surgical Group, commented, "The one-year results from STITCH are compelling as the data challenges the notion that HCTs have an unacceptably low rate of repair success when in fact, they have comparable success rates to those of other meniscal tears."
The STITCH Study will continue to follow patients for two years post-operatively.
References
1 Metcalf MH, Barrett GR. Prospective Evaluation of 1485 Meniscal Tear Patterns in Patients with Stable Knees. AJSM. 2004;32(3):675-680
2 Beamer et al. Changes in Contact Area in Meniscus Horizontal Cleavage Tears Subjected to Repair and Resection. JARS.2017;33(3):617-624
3 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
4 Kurzweil PR, Lynch, NM, Coleman S, Kearney B. Repair of Horizontal Meniscus Tears: A Systematic Review. Arthroscopy. 2014;30(11):1513-1519
5 Abrams GD, Frank RM, Gupta AK, Harris JD, McCormick FM, Cole BJ. Trends in Meniscus Repair and Meniscectomy in the United States, 2005-2011
6 2018 SmartTRAK US Meniscal Repair Fixation market report