Cervical Disc DiseaseNCT05691231
Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
An observational study of Cervical Disc Disease and Degenerative Disc Disease, run by NuVasive at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Disc Disease, Degenerative Disc Disease
- What is being tested?
- NuVasive Simplify Cervical Artificial Disc
- Type of treatment
- Medical device
- How many people
- 158 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jan 2023to 10 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes subjects treated with the NuVasive Two Level Simplify Disc in IDE study (NCT03123549) and followed in the PAS (NCT04980378).
Who may be able to join
- 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
Who cannot join
- 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- Subject was withdrawn or withdrew consent to participate in the IDE study (NCT03123549) or PAS (NCT04980378)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 28204
Texas Back Institute
Plano, Texas, 75093
About this study
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).
- Conditions
- Cervical Disc Disease, Degenerative Disc Disease
- Being tested
- NuVasive Simplify Cervical Artificial Disc
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuVasive Simplify Cervical Artificial DiscDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Simplify Disc | Extended follow-up of subjects treated with the Simplify Disc during IDE study NCT03123549 and followed in the post-approval study NCT04980378. Receives: Device: NuVasive Simplify Cervical Artificial Disc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (12)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start18 Jan 2023
- Primary completion10 Feb 2029 (estimated)
- Study completion10 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyle Malone, Study director, NuVasive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691231
- Sponsor's protocol ID
- NUVA.TDR1022
- Status last verified
- Dec 2025
- First submitted
- 11 Jan 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
- ClinicalTrials.gov ID
- NCT05691231
- Acronym / sponsor ID
- NUVA.TDR1022
- Conditions
- Cervical Disc Disease, Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 10 Feb 2029 (estimated)
- Study completion
- 10 May 2029 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simplify Disc | – | Device: NuVasive Simplify Cervical Artificial DiscExtended follow-up of subjects treated with the Simplify Disc during IDE study NCT03123549 and followed in the post-approval study NCT04980378. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes subjects treated with the NuVasive Two Level Simplify Disc in IDE study (NCT03123549) and followed in the PAS (NCT04980378).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NuVasive Simplify Cervical Artificial DiscSimplify 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. | Device | Simplify Disc |
Primary outcome
Clinical Composite Success Rate
Time frame: 10 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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyle Malone study director
NuVasive
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Disc Disease and Degenerative Disc Disease, run by NuVasive at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Composite Success Rate (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.