Centinel Spine, pioneers of STALIF C, has recently delivered several market-leading innovations in cervical spinal fusion procedures. The most recent milestone is a multilevel* indication for the STALIF C and STALIF C-Ti product family making these the first and only stand-alone cervical integrated interbody devices with this indication.
"As early adopters, we recognized the benefits of the device for multilevel placement and have completed a retrospective review that demonstrated excellent radiographic outcomes when using the device for multilevel fusions," says Joseph C. Maroon, MD, director of Tri-State Neurosurgical Associates-UPMC and clinical professor of neurological surgery at the University of Pittsburgh. Results of this retrospective review will be presented at the 2015 annual meeting of the Congress of Neurological Surgeons in New Orleans, LA.
In recent news about their achieved milestones, Centinel Spine explained its heritage in innovation is founded on several STALIF principles:
• a stand-alone, no profile device that reduces soft tissue irritation;
• immediate biomechanical stability to resist movement;
• similar rigidity to traditional cervical plates and screws;
• compression on the graft in accordance with Wolff’s law; and
• optimized load transfer to assist in promoting fusion.
"STALIF C is faster to implant then a cage and plate construct because you don't have to check frequent x-rays to make certain that the plate and screws are properly placed," says Richard Guyer, MD, co-founder of the Texas Back Institute in Plano, Texas. "With the traditional plate method, you have more soft tissue dissection, so it's a lengthier procedure. The STALIF C implantation saves operative time for the patient due to the minimal amount of soft tissue dissection. The less soft tissue you have to dissect, the less chance you have of running into postoperative problems such hematoma formation and swelling causing difficulty swallowing."
Dr. Guyer added, "The other challenge is that it's not uncommon to see patients come back years later with a cage fusion where there is heterotopic bone forming or impingement on the next level. I haven't seen that with the STALIF device." Furthermore, Dr. Guyer hasn't had to perform a revision in patients with a STALIF C implant since he began using the device more than two years ago.
Laboratory evaluations have shown the STALIF C device to be biomechanically equivalent to a cage and plate, in both one- and two-level fusion constructs. A 2014 in vitro biomechanical study published in The Spine Journal, Biomechanical Analysis of an Interbody Cage with Three Integrated Cancellous Lag Screws in a Two-Level Cervical Spine Fusion Construct by Nayak, et al., concluded the anchored cage with the three screws "afforded biomechanical stability compared to that of the standard interbody cage (plus) anterior plate cervical spine fusion approach."
Another study, Retrospective Clinical Outcome Study Evaluating the Efficacy of the Stand- Alone Cervical Device in Anterior Cervical Discectomy and Fusion, by Amir Vokshoor, MD, of DISC Sports & Spine Center in California, examined 51 patients who underwent single or multilevel fusions with STALIF C. There was a 92.2 percent fusion rate with all patients at 24 months after surgery and all exhibited solid fusions at all operative levels.
With the recent trends in new interbody cage materials and building upon their clinical success, Centinel Spine introduced Ti-ACTIVE, a texturized titanium coating, on its STALIF C product family. According to the Company, the Ti-ACTIVE coating is applied through a proprietary application process with reproducible and uniform thickness, as well as controlled porosity. The texturized coating creates a three-dimensional topography that delivers immediate implant stabilization and an optimized environment to assist in cellular attachment and proliferation.
"I no longer just look for the bone growing through the cage; I also look at the boney apposition of the vertebral endplates to the titanium coating," says Dr. Guyer. "The bone growth on the cage happens faster than the bone graft we use inside the cage. I feel more secure as a clinician when I can see good bony apposition to the device endplates. That's another factor in which we can re-assure the patient that he or she is getting good results (i.e., fusion)."
"The new indication also means that more insurance companies will approve spinal fusions with STALIF C-Ti at multiple levels," says Dr. Guyer. "In the past, insurance companies might have said they wouldn't cover the new technology, but now in the majority of my cases for the appropriately indicated patients, STALIF C-Ti is my 'go-to' fusion device."
* Multilevel indicates use at one to two contiguous levels.
*This article is sponsored by Centinel Spine.