Prodisc C may be safe, effective at 24 months for symptomatic cervical disc disease
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Key takeaways:
- Early composite clinical success showed similar outcomes for the investigational and comparison groups.
- Researchers will follow up with patients until they reach 100% at 2 years.
Early results of an investigational device exemption clinical trial showed two prodisc C implants may be safe and effective for the treatment of symptomatic cervical disc disease at two levels compared with the Mobi-C implant at 24 months.
“Cervical total disc replacements have become their own standard of care,” Celeste Abjornson, PhD, director of spinal research at Hospital for Special Surgery, told Healio about results presented at the North American Spine Society Annual Meeting. “Studies like this show that the results, regardless of design, are promising and that there is going to be a paradigm shift in the marketplace. In the future, looking at studies like this will adjust a surgeon’s thinking to [consider patients for] a disc replacement first and then look at fusion as a secondary option, where in the past, surgeons looked at fusion because that was the classical standard.”
Early results
Abjornson and colleagues randomly assigned 433 patients with symptomatic cervical disc disease at two levels to receive the prodisc C Vivo implant or prodisc C SK implant (Centinel Spine; investigational group) or the Mobi-C Cervical Disc implant (HighRidge formally ZimVie; control group). Researchers considered the primary endpoint as composite clinical success at 24 months, where a patient must have a 15-point or more improvement in neck disability index (NDI) score and maintenance or improvement in neurological status at 24 months compared with baseline, no secondary surgical interventions at the index level and absence of major device-related adverse events.
At 50% of patients reaching 24-month follow-up, results demonstrated similar success outcomes in both groups. If the study continues to trend similarly until final data, it will confirm noninferiority of the investigational implant to the FDA-approved control-arm implant at two levels, according to researchers. Researchers also found early results to show no statistical differences between the two groups in terms of NDI success, major device-related adverse events or neurological status. Although early results showed patients in the control group had a higher incidence of secondary surgical interventions vs. patients in the investigational group, researchers found this was not statistically different.
FDA trial
Although an adaptive Bayesian model allowed for first data analysis at 50% of patients reaching 24-month follow-up, Abjornson said the study will follow all patients until they reach 24 months.
“We are going to continue to follow-up patients until we reach 100% at 24 months,” Abjornson said. “The surgeons are actively seeing all the patients in follow up. The next step is to submit the clinical and safety data to the FDA because it is an [investigational device exemption] IDE clinical trial. The submission is to seek approval [for two levels].”
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Abjornson C, et al. Disc to disc: Early results of the multicenter, prospective, randomized clinical investigational device exemption trial comparing a novel total disc replacement (TDR) to an approved TDR control at two contiguous levels of the cervical spine. Presented at: North American Spine Society Annual Meeting; Sept. 23-28, 2024; Chicago.
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