Cervical Degenerative Disc DiseaseNCT02667067
Investigation of the Simplify® Cervical Artificial Disc
A study testing Simplify Disc and Anterior Cervical Discectomy & Fusion in people with Cervical Degenerative Disc Disease, run by NuVasive at 16 sites in United States.
Trial summary
This study is intended to demonstrate that the Simplify® Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat one level between C3 to C7 for cervical degenerative disc disease (DDD) defined as intractable radiculopathy (arm pain and/or a neurological… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervical Degenerative Disc Disease
- What is being tested?
- Simplify Disc and Anterior Cervical Discectomy & Fusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 16 sitesUnited States
- Study dates
- Nov 2015to 29 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be between 18 and 60 years of age;
- Have symptoms of cervical degenerative disc disease (DDD) at one cervical level from C3 to C7 defined as intractable radiculopathy (arm pain and /or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space and radiographic evidence of at least one of the following;
- Spondylosis (defined by the presence of osteophytes or dark disc) on CT or MRI or;
- Disc height decreased by ≥ 1 mm when compared to adjacent levels on radiographic film, CT, or MRI or
- Disc herniation on CT or MRI;
- Have at least one of the following radiculopathy or myelopathy symptoms in neck and/or arm;
Show all 17Show fewer
- Pain or paresthesias in a specific nerve root distribution from C3 to C7,
- Decreased muscle strength of at least one level on the 0-5 scale, or
- Abnormal sensation, including hyperesthesia or hypoesthesia.
- Have at least one of the following:
- At least six weeks of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications and muscle relaxants at the manufacturer's recommended therapeutic dose);
- The presence of progressive symptoms (e.g., increasing numbness or tingling) or
- Signs of nerve root compression.
- Have a Neck Disability Index (NDI) greater than or equal to 40 on a scale of 100 (moderate disability);
- Be appropriate for treatment using an anterior surgical approach;
- Be likely to return for all follow-up visits and
- Be willing and able to provide Informed Consent for study participation.
Who cannot join
- Marked cervical instability on resting lateral or flexion/ extension X-ray (translation > 3 mm or > 11 degrees rotation to that of either adjacent non-treatment level);
- Non discogenic neck pain or non discogenic source of symptoms (e.g., tumor, rotator cuff injury, etc.);
- Radiographic confirmation of severe facet disease or facet degeneration;
- Bridging osteophytes;
- Less than 2 degrees of motion at index level;
- Prior surgery at the level to be treated, except laminotomy without accompanying facetectomy;
Show all 34Show fewer
- Prior fusion at any cervical level;
- More than one neck surgery via anterior approach;
- Previous trauma to the C3-C7 levels resulting in compression or bursting;
- Documented presence of a free nuclear fragment at cervical levels other than the study level;
- Axial neck pain only (no radicular or myelopathy symptoms);
- Symptomatic DDD at more than one cervical level;
- Severe myelopathy (less than 3/5 muscle strength);
- Any paralysis;
- Recent history (within previous six months) of chemical or alcohol dependence;
- Active systemic infection;
- Infection at the site of surgery;
- Prior disc space infection or osteomyelitis in the cervical spine;
- Any terminal, systemic or autoimmune disease;
- Metabolic bone disease (e.g., osteoporosis/osteopenia , gout, osteomalacia, Paget's disease);
- Any disease, condition or surgery which might impair healing, such as;
- Diabetes mellitus requiring daily insulin management,
- Active malignancy,
- History of metastatic malignancy.
- Current or extended use (> 6 months) of any drug known to interfere with bone or soft tissue healing;
- Known PEEK, ceramic, titanium allergy;
- Arachnoiditis;
- Significant cervical anatomical deformity at the index level or clinically compromised cervical vertebral bodies at the index level due to current or past trauma (e.g., by radiographic appearance of fracture callus, malunion, or nonunion) or disease (e.g., ankylosing spondylitis, rheumatoid arthritis);
- Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin;
- Pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery ;
- Use of spinal stimulator at any cervical level prior to surgery;
- Currently a prisoner;
- Currently involved in spinal litigation which may influence the subjects reporting of symptoms or
- Participation in any other investigational drug, biologic or medical device study within the last 30 days prior to study surgery.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Study site
Addison, Texas
Study site
Carmel, Indiana
Study site
Charlotte, North Carolina
Study site
Egg Harbor, New Jersey
Study site
Evanston, Illinois
Study site
La Jolla, California
Study site
Lockport, New York
Study site
Orange, California
Study site
Paducah, Kentucky
Study site
Plano, Texas
Study site
Reston, Virginia
Study site
Santa Monica, California
Study site
Sarasota, Florida
Study site
Shreveport, Louisiana
Study site
Thornton, Colorado
Study site
Tyler, Texas
About this study
Official title: Clinical Study Protocol for the Investigation Of The Simplify® Cervical Artificial Disc
This study is intended to demonstrate that the Simplify® Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat one level between C3 to C7 for cervical degenerative disc disease (DDD) defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space in subjects who are unresponsive to conservative management.
Read the detailed description
The objective of this clinical study is to evaluate the safety and effectiveness of the Simplify® Disc for treatment of DDD compared to conventional ACDF for reconstruction of the disc space at one level between C3 to C7 for DDD defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space that is unresponsive to conservative management.
- Conditions
- Cervical Degenerative Disc Disease
- Being tested
- Simplify Disc, Anterior Cervical Discectomy & Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplify DiscDevice
Simplify Disc at one level in the cervical spine.
Anterior Cervical Discectomy & FusionDevice
Also called ACDF
This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®|C Disc trial.
| Study group | Role | What they receive |
|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Other | Not described Receives: Device: Anterior Cervical Discectomy & Fusion |
| Simplify Disc | Experimental | Simplify Disc Receives: Device: Simplify Disc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Composite Clinical Success (CCS) of Simplify Disc
Individual success for the Simplify® Disc subjects is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months of index procedure; and the absence of major adverse events within 24 months.
Individual success for the control ADCF device subjects is defined as at least a 15 point improvement in NDI Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months; and the absence of major adverse events within 24 months.
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: Baseline, 24 Months
Secondary outcomes (15)
Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery)
Time to recovery is defined as time to first 15-point improvement in NDI 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: Baseline, 3 Months
VAS Neck and Arm Pain
Changes of at least 20 mm on a 100mm will be regarded as clinically significant VAS 0mm (no pain); VAS 100mm (worst pain)
Measured: Baseline, 24 Months
Neurological Status
Neurological success was defined as maintenance or improvement in neurologic status at Month 24 as compared to baseline, as determined by the independent Clinical Events Committee (CEC). The CEC reviews neurological exams of motor, sensory, reflex, clumsiness, atrophy, cramping, spasms, numbness, dysphagia, dysphonia, and myelopathic gait to make an adjudication determination.
Measured: Baseline, 24 Months
SF-12 Physical Component Score (PCS) Maintenance or Improvement
The PCS is a sub-score of the SF-12. The SF-12 is a multipurpose short form survey with 12 questions all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related-quality of life. Higher scores indicate better outcomes. Scores range from 0-50.
Data was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Measured: Baseline, 24 Months
SF-12 Mental Component Score (MCS) Maintenance or Improvement
The MCS is a sub-score of the SF-12. The SF-12 is a multipurpose short form survey with 12 questions all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related-quality of life. Higher scores indicate better outcomes. Scores range from 0-50.
Data was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Measured: Baseline, 24 Months
Patient Questionnaires- Treatment Satisfaction Health Survey-
Question 1 - "how does the subject rate satisfaction with the treated received" was compared between groups at Month 24. Answer options ranged from very dissatisfied to very satisfied.
Measured: 24 Months
Odom's Criteria Results
Results at 24 months for the investigational Simplify® Disc and at 24 months for the control ACDF will also be categorized by the physician according to Odom's Criteria.
Measured: 24 Months
Dysphagia Handicap Index (DHI)
Dysphagia Handicap Index (DHI scale) for the investigational Simplify® Disc at 24 months compared to baseline. A higher score is indicative of a less desirable outcome. It is scored 0-100.
Data was not collected on DHI in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Measured: Baseline, 24 Months
Average Disc Height (Index Level)
Change in average disc height (index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights.
Measured: Baseline, 24 Months
Average Disc Height (Above the Index Level)
Change in average disc height (Above the index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights.
Measured: Baseline, 24 Months
Average Disc Height (Below the Index Level)
Change in average disc height (below the index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights.
Measured: Baseline, 24 Months
Superior Adjacent Level Disc Degeneration
Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level.
Measured: Baseline, 24 Months
Inferior Adjacent Level Disc Degeneration
Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level.
Measured: Baseline, 24 Months
Device Migration
Device migration assesses significant movement of the implant postoperatively
Measured: Baseline, 24 Months
Facet Deterioration
Facet degeneration was assessed using MRI for the investigational Simplify Disc at 24 months compared to baseline.
Facet degeneration was not assessed in the ACDF historical control group, as there is no 24 month MRI. This was pre-specified in the study design.
Measured: Baseline, 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startNov 2015
- Primary completion23 Mar 2020
- Study completion29 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical Degenerative 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
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
- NCT02667067
- Sponsor's protocol ID
- G140154
- Status last verified
- Dec 2025
- First submitted
- 8 Oct 2015
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Protocol for the Investigation Of The Simplify® Cervical Artificial Disc
- ClinicalTrials.gov ID
- NCT02667067
- Acronym / sponsor ID
- G140154
- Conditions
- Cervical Degenerative Disc Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Posted 6 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to demonstrate that the Simplify® Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat one level between C3 to C7 for cervical degenerative disc disease (DDD) defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space in subjects who are unresponsive to conservative management.
Detailed description
The objective of this clinical study is to evaluate the safety and effectiveness of the Simplify® Disc for treatment of DDD compared to conventional ACDF for reconstruction of the disc space at one level between C3 to C7 for DDD defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space that is unresponsive to conservative management.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Other | Device: Anterior Cervical Discectomy & Fusion |
| Simplify Disc | Experimental | Device: Simplify DiscSimplify Disc |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Be between 18 and 60 years of age;
- Have symptoms of cervical degenerative disc disease (DDD) at one cervical level from C3 to C7 defined as intractable radiculopathy (arm pain and /or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space and radiographic evidence of at least one of the following;
- Have at least one of the following radiculopathy or myelopathy symptoms in neck and/or arm;
- Have at least one of the following:
- Have a Neck Disability Index (NDI) greater than or equal to 40 on a scale of 100 (moderate disability);
Key exclusion criteria (34 listed)
- Marked cervical instability on resting lateral or flexion/ extension X-ray (translation > 3 mm or > 11 degrees rotation to that of either adjacent non-treatment level);
- Non discogenic neck pain or non discogenic source of symptoms (e.g., tumor, rotator cuff injury, etc.);
- Radiographic confirmation of severe facet disease or facet degeneration;
- Bridging osteophytes;
- Less than 2 degrees of motion at index level;
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 |
|---|---|---|
| Simplify DiscSimplify Disc at one level in the cervical spine. | Device | Simplify Disc |
| Anterior Cervical Discectomy & FusionAlso: ACDFThis study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®|C Disc trial. | Device | Anterior cervical discectomy & fusion (ACDF) |
Primary outcome
Number of Participants With Composite Clinical Success (CCS) of Simplify Disc
Time frame: Baseline, 24 Months
Individual success for the Simplify® Disc subjects is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months of index procedure; and the absence of major adverse events within 24 months. Individual success for the control ADCF device subjects is defined as at least a 15 point improvement in NDI Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months; and the absence of major adverse events within 24 months. 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.
15 secondary outcomes
Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery)
Time frame: Baseline, 3 Months
VAS Neck and Arm Pain
Time frame: Baseline, 24 Months
Neurological Status
Time frame: Baseline, 24 Months
SF-12 Physical Component Score (PCS) Maintenance or Improvement
Time frame: Baseline, 24 Months
SF-12 Mental Component Score (MCS) Maintenance or Improvement
Time frame: Baseline, 24 Months
Patient Questionnaires- Treatment Satisfaction Health Survey-
Time frame: 24 Months
Odom's Criteria Results
Time frame: 24 Months
Dysphagia Handicap Index (DHI)
Time frame: Baseline, 24 Months
Average Disc Height (Index Level)
Time frame: Baseline, 24 Months
Average Disc Height (Above the Index Level)
Time frame: Baseline, 24 Months
Average Disc Height (Below the Index Level)
Time frame: Baseline, 24 Months
Superior Adjacent Level Disc Degeneration
Time frame: Baseline, 24 Months
Inferior Adjacent Level Disc Degeneration
Time frame: Baseline, 24 Months
Device Migration
Time frame: Baseline, 24 Months
Facet Deterioration
Time frame: Baseline, 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Kyle Malone study director
NuVasive
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simplify Disc and Anterior Cervical Discectomy & Fusion in people with Cervical Degenerative Disc Disease, run by NuVasive at 16 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 17 inclusion and 34 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: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
Yes. Results are posted in the registry (first posted 6 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Composite Clinical Success (CCS) of Simplify Disc (time frame: Baseline, 24 Months). 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 8 Jan 2026.