Ceterix Begins Meniscus Repair Suture Passer Trial

Menlo Park, Calif.-based Ceterix Orthopaedics Inc., which makes surgical tools for arthroscopic procedures, today announced enrollment of the first patient in Stitch (a prospective, non-randomized, multi-center investigation of all-suture-based repair of horizontal meniscal tears), a new evaluation of suture-based meniscal repair for patients with horizontal meniscus tears, a common type of knee injury.

Patients with horizontal cleavage tears often undergo meniscectomy—partial removal of the meniscus—because common opinion has held that meniscus repair is not effective for this tear type, despite meniscectomy’s well-established limitations and long-term consequences, including the increased risk of arthritis. Additionally, a recently published systemic literature review shows that healing rates for horizontal cleavage tears are comparable to other meniscal tear types that are routinely repaired.

The primary objectives of the Stitch study are to assess the success of horizontal meniscus tear repair using the company’s Novostitch suture passer or other suture-only techniques, and to assess improvements in knee pain and function after repair. The study will include 30 patients at up to 10 investigational sites in the United States.

“Since the early days of meniscal repair surgery, it has been often repeated, on the podium and in and publications, that horizontal cleavage tears cannot be repaired due to their degenerative nature,” said orthopaedic surgeon Peter Kurzweil, M.D., principal investigator of the Stitch study. “This study is designed to further investigate whether these types of tears can indeed heal, as the literature review suggests, when repaired with suture-based therapy.”

Arthroscopic surgery is a minimally invasive surgical procedure performed by an orthopedic physician in which a damaged joint is treated, through small incisions with specialized tools, under the guidance of a tiny camera called an arthroscope. Meniscus surgeries are the most common arthroscopic surgery in the United States, with roughly one million procedures annually.

Ceterix’s Novostitch suture passer is designed to place stitches arthroscopically in tight joint compartments and thereby address complex knee, hip and shoulder injuries that have not been amenable to repair in the past.