The Cartiva Synthetic Cartilage Implant is designed for use in patients with osteoarthritis of the first metatarsophalangeal joint. The trial compares the implant with today’s industry standard solution — arthrodesis — for reducing pain. Here, Mark Glazebrook, MD, associate professor of orthopedic surgery at Queen Elizabeth Science Centre in Nova Scotia, and Carticept CEO Timothy Patrick discuss the new implant and where it is headed in the future. Dr. Glazebrook is also participating in the clinical trial.
Q: What makes this implant different from others on the market?
Dr. Mark Glazebrook: Currently, the gold standard for treatment of toe arthritis is fusion. We are now conducting the largest randomized controlled trial comparing fusion with arthroplasty. If the results are as they should be, we will have an alternative to fusion. This arthroplasty is bone preserving, so it leaves the option to do a fusion in the future, if necessary. The procedure also preserves motion of the toe joint, which is something patients constantly request when it comes to surgery.
Q: What benefit do you expect to see from using the Cartiva Synthetic Cartilage Implant?
Timothy Patrick: One of the benefits of using our system is that patients can maintain a natural rotation of movement in the toe and reserve the anatomy for future surgery. The procedure isn’t a fusion or a joint replacement that would require bone to be removed from both sides of the joint; what we are really doing is resurfacing the MTP head with a hydrogel polymer.
It’s a simple surgical procedure that takes 20 to 30 minutes and only focuses on the MTP side. We end up with a polymer cartilage replacement that cushions the phalangeal part of the toe that has an elastic surface. Usually that is gone or highly damaged by the time of surgery.
Q: Which patients would benefit most from the procedure?
TP: It would mostly be for patients that have arthritis or pain in the toe. Some patients may have bone spurs or bone growth that causes the pain. Generally those patients would have a cartilage defect that is quite difficult on the MTP head. The cartilage defect on the MTP head is what we are repairing with our implant.
Q: Will the procedure be hard for surgeons to incorporate into their practice?
MG: It’s a very simple, straight forward and timely procedure. It’s easy for surgeons to learn the technique. If the results of our trial are promising, I think we are going to see surgeons choosing fusion less often and doing more joint replacements.
Q: Where do you see the technology headed in the future?
MG: I would anticipate we’ll see similar pain relief for the arthroplasty compared to the fusion with the added benefit of people being able to recover quickly. When patients have a fusion they are in a cast for six weeks; when we do an arthroplasty procedure patients can be mobilized within one or two weeks, therefore patients do get back on their feet faster.
TP: Our launch is still a couple years down the road for us in the United States. Right now we are really evaluating the options in terms of whether we would do that directly or with distribution. First, we’ll be following patients in the trial in Canada and the United Kingdom for two years. Generally, the FDA wants to see a few years follow-up information in the new orthopedic implantable products so that’s what we are doing with this patient cohort.
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