surgery with a Titan implant, and it will primarily measure the rate of successful fusions and whether or not patients’ conditions improved. The company intends to publish the trial results in about two years.
It’s important to note that the trial won’t directly compare Titan’s products with competing types of implants, though—according to Ullrich, the cost of doing such a randomized trial in the U.S. would be too high. That’s partly why Titan intends to participate in the FDA’s Medical Device Epidemiology Network Initiative to collect data on spinal fusion patients and compare outcomes of surgeries using Titan products with those conducted with other types of implants, particularly plastic, he says. The idea behind the project, whose scope expands beyond spinal implants, is for industry and government officials to share information that leads to better understanding of the safety and efficacy of medical devices that have already hit the market.
Meanwhile, a Titan-sponsored retrospective study published in the International Journal of Spine Surgery in 2013 examined 82 patients who underwent surgery using a combination of a Titan implant and Bacterin’s OsteoSponge bone graft material. The fusion rate for one set of patients was 93 percent after six months and 97 percent after a year for the other group, with no surgical or device-related complications.
Results from a separate prospective study involving 77 patients were presented at an industry conference in 2013, but the full results have not been published in a medical journal. Those patients underwent spinal fusions with a Titan implant and Medtronic’s Infuse bone graft material, which contains a genetically engineered protein meant to stimulate bone growth. The study resulted in a 100 percent fusion rate, and the fusions were still holding strong after two years, according to a spring 2014 article in the Journal of the Spinal Research Foundation by Titan chief medical officer Paul Slosar, a California surgeon and co-author of the study. In addition, a majority of the patients reported decreased pain after the surgery, and there were no reported issues related to the devices, Slosar wrote.
It’s worth pointing out that Titan doesn’t have FDA approval to market its devices for use in combination with substances like Infuse—only for use with a graft of the patient’s own bone taken from another part of the body—but the company can’t control how surgeons use its products, Gemas says. The study involving Infuse was not sponsored by Titan, Ullrich says.
If, however, Titan’s products can demonstrate in humans the ability to coax enough natural production of the proteins like those found in Infuse, that could be a differentiator for the company, Liang says. Infuse’s synthetic protein is expensive, he says, and has been associated with complications, including a possible link to cancer, according to reports in the Milwaukee Journal Sentinel.
Needless to say, there’s a lot riding on Titan’s clinical trial and gathering enough comparative data through the FDA project. Should those initiatives go the way Titan executives hope, they could provide the company the data it needs to stand out in a competitive, contentious field.
“We’re very confident our product will stack up extremely well,” Ullrich says.
