FREMONT, Calif.--(BUSINESS WIRE)--Ceterix® Orthopaedics, Inc., a developer of novel surgical tools that improve a surgeon’s ability to perform minimally invasive orthopaedic procedures, today announced completion of enrollment in STITCH (A Prospective, Non-randomized, Multi-Center Investigation of All-suture-based Repair of Horizontal Meniscal Tears1), the first-ever prospective multicenter investigation of suture-based repair for patients with horizontal meniscus tears, a common type of knee injury.
Because common opinion has held that meniscus repair is not effective for this tear type, horizontal cleavage tears are often treated with meniscectomy – partial removal of the meniscus – despite meniscectomy’s well-established limitations and long-term consequences, including the increased risk of arthritis.2 In fact, a systemic literature review shows that healing rates for horizontal cleavage tears are comparable to other meniscal tear types that are routinely repaired3, suggesting that more horizontal cleavage tears could be repaired, saving patients the risks of meniscectomy.
The primary objectives of the STITCH study are to assess the success of horizontal meniscus tear repair using Ceterix’s NovoStitch® meniscal repair system or other suture-only techniques, and to assess improvements in knee pain and function after repair. The study targeted enrollment of 30 adults who are 60 and younger at 10 investigational sites in the United States.
“This study aimed to establish the therapeutic value of repair of horizontal tears in multiple practices and across a broad age range,” said orthopaedic surgeon Peter Kurzweil, M.D., principal investigator of the STITCH study. “This study will provide the most credible evidence yet available about this very prevalent and important tear type.”
Arthroscopic surgery is a minimally invasive surgical procedure performed by an orthopaedic surgeon 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.
“We are proud to invest in increased understanding of the benefits of our technologies,” said John McCutcheon, president and CEO of Ceterix. “We hope that the results of this study will mean that more patients are spared the potential downsides of meniscectomy through increased use of suture-based repair for these types of tears.”
Ceterix’s NovoStitch meniscal repair system enables surgeons 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.
About Ceterix® Orthopaedics
Ceterix® Orthopaedics develops surgical tools that expand and improve what is possible for physicians who treat soft tissue joint injuries such as meniscus tears. Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix’s novel meniscal repair system enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The NovoStitch Plus meniscal repair system has received 510k clearance in the United States and is indicated for approximation of soft tissue in meniscal repair procedures. The company is based in Fremont, Calif. and is backed by investors Versant Ventures, 5AM Ventures and CRG. For more information, please visit www.ceterix.com.
2 Papalia, R. et. al. Meniscectomy as a risk factor for knee osteoarthritis: a systematic review. British Medical Bulletin. 2011; 99:89-106.
3 Kurzweil, P. et.al. Repair of Horizontal Meniscus Tears: A Systematic Review. Arthroscopy. 2014 Aug 6.