An observational study in Cervical Disc Disease and Degenerative Disc Disease, sponsored by NuVasive. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by NuVasive (part of Globus Medical) · Observational
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).
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's planned enrollment of 158 is above the median of 119 across 170 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →NuVasive is the lead sponsor of 38 studies on the registry; 8 are open to participants now.
First submitted before NuVasive became part of Globus Medical.
Counted across the registry records on this site, refreshed daily.
The study population includes subjects treated with the NuVasive Two Level Simplify Disc in IDE study (NCT03123549) and followed in the PAS (NCT04980378).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Extended follow-up of subjects treated with the Simplify Disc during IDE study NCT03123549 and followed in the post-approval study NCT04980378.
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.
Clinical Composite Success Rate
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.
Time frame: 10 years
Percentage of subjects meeting the minimal clinically important difference (MCID) for NDI at each annual timepoint
Neck Disability Index; scale is reported in a range from 0-100, with 0 consistent with best ability to function and 100 worst ability to function.
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.
Neck and arm pain questionnaire, scale is reported in a range from 0 to 10, with 0 consistent with no pain and 10 with most pain
Time frame: 10 years
Motor status at each annual timepoint compared to baseline
A change of one or more grade levels in muscle strength will be regarded as clinically significant.
Time frame: 10 years
Sensory status at each annual timepoint compared to baseline
Sensation will be graded as normal or abnormal (diminished or absent). Any changes from abnormal to normal or absent to diminished will be regarded as clinically significant improvement.
Time frame: 10 years
SF-36® Health Survey at each annual timepoint compared to baseline
The SF-36 is a multipurpose survey with 36 questions. The questions were combined, scored and weighted to create mental and physical functioning and overall health-related quality of life. Higher scores indicate better outcomes. Scores range from 0-100.
Time frame: 10 years
Dysphagia Handicap Index1 (DHI) at each annual timepoint compared to baseline
DHI is scored from 0-100, with a higher score indicative of a less desirable outcome.
Time frame: 10 years
Disc height at each annual timepoint will be compared to baseline
Average disc height is calculated as the simple average of the anterior and posterior disc heights
Time frame: 10 years
Adjacent level disc degeneration (ALDD) at each annual timepoint will be compared to baseline
ALDD is graded in accordance with definitions adapted from Kellgren and Lawrence: None; Doutbtful;Minimal;Moderate;Severe
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)
Device migration assesses significant movement of the implant postoperatively. Changes of \>3 mm will be considered significant due to the margin of error in radiographic determination of displacement distances.
Time frame: 10 years
Range of motion (ROM) at each annual timepoint compared to baseline
Changes in Global Range of Motion will be calculated by subtracting the range of motion measured at one time point from the baseline range of motion. Change in Global Range of Motion will be reported in units of degrees.
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
Number of adverse events related to Simplify Disc or additional NuVasive products
Time frame: 10 years
Patient satisfaction and perceived effect at each annual timepoint
Patient questionnaire assessing satisfaction with treatment and perceived effect of treatment. Success for each satisfaction question will be defined as either a "Definitely True" or "Mostly True" response. Success for the perceived effect question will be defined as either a "Completely Recovered," "Much Improved," or "Slightly Improved" response.
Time frame: 10 years
Plan to share: No
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Intervertebral Disc Degeneration →