The STALIF C-Ti integrated cage-screw implant (Centinel Spine) has demonstrated statistically significant and clinically meaningful improvements in all available patient reported outcome scores out to 12 months, a new prospective multicentre study has found.
The study, the findings of which were published in the Journal of Surgery & Anesthesia Research by Jad Khalil (William Beaumont Hospital, Royal Oak, USA) et al, also showed that the STALIF C-Ti device is associated with minimal complication rates at 12 months.
Although observed fusion rates were lower than reported literature comparisons, no radiographic device related complications and only one incidence of subsidence was noted. In addition, low rates of both dysphagia and serious/device related adverse events were reported at 12 months.
A total of 145 patients (average age 50.11 years; 45% male) were included in the study. All patient reported outcomes scores, including Neck Disability Index (NDI), Visual Analogue Scale (VAS) Neck, VAS Left Arm and VAS Right Arm, demonstrated statistically significant improvements at six-weeks follow-up and were maintained out to 12-month follow-up.
Six weeks follow-up NDI decreased to 33.30 (p<0.001, 18.30-point decrease), VAS Neck decreased to 29.89 (p<0.001, 41.34-point decrease), VAS Right Arm decreased to 21.43 (p<0.001, 30.04-point decrease), and VAS Left Arm decreased to 18.73 (SD p<0.001, 26.6-point decrease).
Twelve-month outcome scores maintained statistically significant improvement over baseline preoperative values. Statistically significant improvements (p<0.001) were maintained out to 12-month follow-up for all patient reported outcome scores: NDI 22.48 (29.77-point decrease), VAS Neck 22.48 (48.43-point decrease), VAS Right Arm 18.77 (32.48-point decrease), and VAS Left Arm 16.67 (26.93-point decrease).
Furthermore, 12-month NDI and VAS neck pain scores exceeded the minimal clinically important difference (MCID) threshold range and VAS arm pain scores were in the upper 50% of reported MCID threshold ranges.
Co-investigator Khalil said: “This is what I believe to be a very important multicentre study on stand-alone devices. There is very little data on stand-alone devices. And, while reference is frequently made comparing cervical fusions, the majority of those references are comparing plated fusions.
“This study was undertaken to determine if there was an advantage to an integrated interbody device over traditional plated fusion. The study was conducted at 11 centres across the country—a mix of private practice and university-based programs, with all data collected and entered into a validated database. I believe this study will be very important in influencing fusion device selection and is long overdue.”
Centinel Spine CEO, Steve Murray, added: “We are committed to providing clinical evidence to support our portfolio of devices and this study is one of the few multicentre prospective clinical evaluations of this type of technology. We are dedicated to advancing evidence that further supports the stand-alone fusion platform that was pioneered by Centinel Spine.”