UK-based medical technology company Smith & Nephew has announced 0% re-operation rate and 100% meniscal healing at six months for a study to evaluate effectiveness of repairing horizontal cleavage tears (HCTs).
HCT is a one of the most common meniscal tears that affects about one-third of patients with this injury. The STITCH study is conducted to examine the effectiveness of repair using Smith & Nephew’s NOVOSTITCH Meniscal Repair System, which is available only in the US. It addressess the complex meniscal tear patterns that are not sufficiently served by other repair systems, including HCTs.
Thirty patients with meniscal tears were enrolled for the STITCH study across eight sites in the US. The study examined three endpoints including 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.
For all three endpoints, results for a period of six months showed 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.
The Ohio State University Wexner Medical Center cartilage restoration program director and STITCH co-author 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.”
HCTs have been treated conservatively or by partial resection, commonly referred to as a meniscectomy, which could put the patient at risk of adverse changes to knee joint, leaving them open to osteoarthritis or total knee replacement later in life.
The NOVOSTITCH device was designed for access and safety in tight knee joints. To expand the meniscal repair option for many patients, the device provides surgeons a potential to place circumferential compression stitches at locations previously not possible.
The company claims that its NOVOSTITCH complements its FAST-FIX◊ 360 Meniscal Repair System, which addresses vertical tears, the most commonly repaired meniscal injury currently.
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.”