Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
At a glance
Conditions
NCT05691231
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolinano site contact published
Texas Back Institute
Plano, Texasno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Kyle Malone · STUDY_DIRECTOR · NuVasive
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Clinical Composite Success Rate10 years
Individual success is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 120 months compared with baseline, maintenance or improvement in neurologic status at 120 months compared with baseline, no additional surgical procedure at the index level within 120 months, and the absence of a serious adverse event classified as implant-associated or implant/surgical procedure-associated within 120 months. A subject must meet each criterion to be considered an overall study success. NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.