Since the early days of mainstream arthroscopic meniscal repair, many inventors have set their minds to the task of developing systems that can deliver clinically successful outcomes to address all pathologies. Ceterix® Orthopaedics, Inc., is one such developer of novel surgical tools. The company has now 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.
Background
Patients with horizontal cleavage tears often undergo partial meniscectomy because common opinion has held that meniscus repair is not effective for this tear type. This is despite meniscectomy’s well-established limitations and long-term consequences, including the increased risk of arthritis. More recently it has been reported that healing rates for horizontal cleavage tears are, after all, comparable to other meniscal tear types that are routinely repaired.
Ceterix clearly reckons its NovoStitch® suture passer is up to the job of delivering neat and functional repairs of horizontal cleavage tears, so has undertaken the STITCH study to prove it. Ceterix says its 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, including repair of horizontal cleavage tears of the meniscus.
The primary objectives of the STITCH study are to assess the success of horizontal meniscus tear repair using the 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 and will assess them up to two years post-procedure. Perhaps significantly it is not a randomized comparative study, so doesn’t offer up the opportunity to assess outcomes of repair against resection with appropriate blinding of patient or assessor. This is a shame and leaves one wondering what the point is. We could perhaps predict that patients will be fine and free from re-operation of the repair site at two years, which is great. But any assessment of knee pain and function and onset of arthritic changes would have benefitted from randomized comparison, in our view
Study details can be found here.
Investigator comments
“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.”
Source: Ceterix, Inc., Business Wire
published: November 24, 2014 in: Arthroscopy, Clinical Studies/Trials, Knee