Enrolling by invitation NCT05691231
Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NuVasive Simplify Cervical Artificial Disc.
- Who it may be relevant to
- Registry conditions: Cervical Disc Disease, Degenerative Disc Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc at two levels in subjects who were enrolled in the IDE study (NCT03123549) and/or post approval study (NCT04980378).
Interventions
- Device NuVasive Simplify Cervical Artificial Disc
Simplify Disc is a weight-bearing cervical artificial disc implant consisting of PEEK (polyetheretherketone) endplates and one semi-constrained, fully articulating, mobile Zirconia Toughened Alumina ceramic (ZTA) core.
Primary outcome measures
- Clinical Composite Success Rate [Time frame: 10 years]
Secondary outcome measures (12)
- Percentage of subjects meeting the minimal clinically important difference (MCID) for NDI at each annual timepoint [Time frame: 10 years]
- Percentage of subjects meeting MCID for neck and arm pain questionnaire for each of the following pain locations: neck pain, arm pain, left arm pain, right arm pain. [Time frame: 10 years]
- Motor status at each annual timepoint compared to baseline [Time frame: 10 years]
- Sensory status at each annual timepoint compared to baseline [Time frame: 10 years]
- SF-36® Health Survey at each annual timepoint compared to baseline [Time frame: 10 years]
- Dysphagia Handicap Index1 (DHI) at each annual timepoint compared to baseline [Time frame: 10 years]
- Disc height at each annual timepoint will be compared to baseline [Time frame: 10 years]
- Adjacent level disc degeneration (ALDD) at each annual timepoint will be compared to baseline [Time frame: 10 years]
- Displacement or migration of the Simplify Disc at each annual timepoint will be compared to the post-op timepoint in the IDE study (NCT03123549) [Time frame: 10 years]
- Range of motion (ROM) at each annual timepoint compared to baseline [Time frame: 10 years]
- Rate of adverse events attributable to Simplify Disc, or use of additional NuVasive instruments, implants, or technologies at each annual timepoint [Time frame: 10 years]
- Patient satisfaction and perceived effect at each annual timepoint [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- Subject was enrolled in the Simplify Disc IDE (NCT03123549) and/or PAS (NCT04980378) at a participating study site
- Patient understands the conditions of enrollment and is willing sign an informed consent form to participate in the study
Exclusion criteria
- Subject had an SSI at the index level during the IDE study (NCT03123549) or the PAS (NCT04980378)
- Subject was withdrawn or withdrew consent to participate in the IDE study (NCT03123549) or PAS (NCT04980378)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 2 centers
- Carolina Neurosurgery and Spine Associates — Charlotte
- Texas Back Institute — Plano
Identifiers
NCT: NCT05691231 · NUVA.TDR1022