Medical technology firm Smith & Nephew has announced positive six-month data from the STITCH trial of its Novostitch Meniscal Repair System.
Novostitch is intended for complex meniscal tear patterns that are not adequately addressed by other repair systems.
The prospective study assessed the effectiveness of the device in repairing common meniscal tears known as horizontal cleavage tears (HCTs) in 30 patients at eight sites across the US.
It assessed meniscal healing at second look needle arthroscopy, freedom from re-operation and improvements in knee pain and function measured as patient reported outcomes (PROs).
At six months, complete meniscal healing was observed upon second look arthroscopy, along with a 0% re-operation rate and significant improvements in all PROs.
STITCH study co-author Dr David Flanigan said: “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.”
Previously, HCTs were treated by partial resection via meniscectomy. However, this procedure is associated with risk of adverse knee joint changes, which could eventually lead to osteoarthritis or total knee replacement.
Novostitch is designed to allow surgeons to make circumferential compression stitches in locations that were not previously possible. This is said to expand the meniscal repair option for several patients.
The device complements Smith & Nephew’s Fast-Fix 360 Meniscal Repair System, which is meant for vertical tears.
Smith & Nephew Global Sports Medicine and ENT president Brad Cannon said: “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.
“With products like Novostitch Pro and Fast-Fix 360 we see the opportunity to double this proportion in the medium term.”
Data from the STITCH trial was presented at the International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS) held in Cancun, Mexico in May.