Cervical Disc DiseaseCerPassNCT01433367
A Clinical Trial Evaluating a Total Disc Replacement in Patients With Cervical Disc Disease
An observational study of Cervical Disc Disease, run by NuVasive at 1 site in Mexico.
Trial summary
This study will be a non-randomized trial consisting of patients with single level (C3 to C7) symptomatic cervical disc disease who have not previously received fusion surgery at the same level, and have failed to improve with conservative treatment for at least 6 weeks prior to enrollment, or who present with… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervical Disc Disease
- What is being tested?
- CerPass® Total Disc Replacement
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 1 siteMexico
- Study dates
- May 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Volunteers will be selected from the surgeon's existing clinic patients.
Who may be able to join
- The criteria for inclusion into the proposed clinical study are as follows:
- Age: 18-60 years of age (inclusive and skeletally mature);
- A diagnosis of symptomatic cervical disc disease, defined as image-confirmed pathology: herniated disc, spondylosis, and/or loss of disc height. Spondylosis is defined as image-confirmed disc desiccation, loss of disc height, bridging osteophytes, and/or uncovertebral arthrosis. Loss of disc height is specified as a measurement of at least 25 degrees less than an adjacent nonsymptomatic level, but with a minimum of 1mm height remaining;
- Functional neurological deficit (i.e., exhibits at least one sign associated with cervical level to be treated, including abnormal reflex, decreased motor strength, abnormal dermatome sensitivity, or pain in a dermatomal distribution);
- Symptomatic level is C3-4, C4-5, C5-6 or C6-7 (one level);
- Preoperative Neck Disability Index (NDI) greater than 30 points (considered moderate disability; Vernon 1991);
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- Unresponsive to conservative treatment for more than 6 weeks, and/or exhibits progressive symptoms and/or signs of nerve root and/or spinal cord compression in the face of conservative treatment;
- Not pregnant, nor interested in becoming pregnant within the follow-up period of the study;
- Willing and able to comply with the requirements defined in the protocol for the duration of the study;
- Signed and dated Informed Consent.
Who cannot join
- Patients with the following characteristics will not be eligible for entry into the proposed study:
- Prior cervical fusion, prior laminectomy (prior cervical laminotomy that has not violated the facets need not be excluded), and/or prior cervical facetectomy at the operative level;
- Requiring surgical treatment that would leave the patient with a postoperative deficiency of the posterior elements;
- Signal changes in the cord on preoperative T2-weighted MRI and/or clinically significant myelopathy which would be described as gait disturbance, loss of manual dexterity, or bowel or bladder incontinence/retention.
- Radiographic signs of significant instability at operative level (greater than 3mm translation, greater than 11 degree rotation different from adjacent level);
- Bridging osteophytes or motion < 3 degrees;
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- Radiographic confirmation of significant facet joint disease or degeneration;
- Chronic neck or arm pain of unknown etiology;
- Cervical fracture, anatomic anomaly, or deformity (e.g. ankylosing spondylitis, scoliosis) at the levels to which the prosthesis will be attached;
- Severe spondylolisthesis (greater than grade 1);
- Endocrine disorders or connective tissue diseases;
- Rheumatoid arthritis or other autoimmune disease;
- Progressive neuromuscular disease, e.g., muscular dystrophy, multiple sclerosis;
- Chronic steroid users;
- Taking any medications or drugs in doses that are known to potentially interfere with the bone metabolism or soft tissue healing, which may include (but is not limited to) the following: inhaled glucocorticoids for asthma, corticosteroids, thyroid hormones, blood thinners (heparin, warfarin), gonadotropin-releasing hormone agonists for prostate cancer treatment, contraceptive medroxyprogesterone, lithium for bi-polar disorder treatment, anticonvulsants, aluminum-containing antacids, tetracycline;
- Osteoporosis to a degree that spinal instrumentation would be contraindicated (DEXA T-score less than or equal to -2.5; DEXA necessary only if patient exhibits risk factors for low bone mass as quantified in DEXA screening questionnaire);
- Diabetes mellitus requiring insulin management;
- Presence of metastases or active spinal tumor malignancy;
- Body Mass Index (BMI) > 40;
- Active local or systemic infection, including AIDS, hepatitis;
- Having been enrolled in another investigational device study within the last 90 days;
- Having had another cervical device implanted that would interfere with the surgical approach, study or control device, or follow-up evaluations;
- Demonstrates 3 or more signs of nonorganic behavior, such as Waddell's signs;
- History of substance abuse;
- Involved in spinal litigation;
- Mentally incompetent;
- Incarcerated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Study Evaluating the Performance of the CerPass® Total Disc Replacement in Patients With Single-Level Cervical Disc Disease
This study will be a non-randomized trial consisting of patients with single level (C3 to C7) symptomatic cervical disc disease who have not previously received fusion surgery at the same level, and have failed to improve with conservative treatment for at least 6 weeks prior to enrollment, or who present with progressive neurological symptoms or signs in the face of conservative treatment.
- Conditions
- Cervical Disc Disease
- Being tested
- CerPass® Total Disc Replacement
- Keywords
- total disc replacement, cervical disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerPass® Total Disc ReplacementDevice
Single level cervical disc disease
| Study group | Role | What they receive |
|---|---|---|
| CerPass® Total Disc Replacement | Not described Receives: Device: CerPass® Total Disc Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoints will be individual patient success at 24 months.
Success is defined as:
Improvement in the Neck Disability Index (NDI) by ≥ 15 points at 24 months compared to Baseline;
No device failures requiring revision, re-operation (including supplemental fixation), or removal from the patient;
Maintenance or improvement of neurologic status (based on sensory, motor, and reflex assessment scores and observational gait analysis).
Measured: 24 months
Secondary outcomes (4)
Range of motion (ROM)
Range of Motion (ROM) defined as more than 3 degrees total flexion / extension. If the ROM is less than or equal to 3º the patient will be defined as having "non-motion."
Measured: 24 months
SF-36
SF-36 improvement of 15% at 24 months compared to Baseline
Measured: 24-months
VAS analog pain scale (VAS)
Visual analog pain scale (VAS) improvement of 20 mm at 24 months compared to Baseline
Measured: 24-months
Disc height improvement
Disc height from the lateral radiograph showing maintenance or improvement from baseline at 24 months.
Measured: 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startMay 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Marketing of CE marked device has been discontinued.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelli Howell, Study director, NuVasive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433367
- Sponsor's protocol ID
- NUVA-CP-0904
- Acronym
- CerPass
- Status last verified
- Dec 2025
- First submitted
- 10 Jun 2011
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Evaluating the Performance of the CerPass® Total Disc Replacement in Patients With Single-Level Cervical Disc Disease
- ClinicalTrials.gov ID
- NCT01433367
- Acronym / sponsor ID
- CerPass / NUVA-CP-0904
- Conditions
- Cervical Disc Disease
- Keywords
- total disc replacement, cervical disc disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Marketing of CE marked device has been discontinued.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Sep 2011 (estimated)
- 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.
This study will be a non-randomized trial consisting of patients with single level (C3 to C7) symptomatic cervical disc disease who have not previously received fusion surgery at the same level, and have failed to improve with conservative treatment for at least 6 weeks prior to enrollment, or who present with progressive neurological symptoms or signs in the face of conservative treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CerPass® Total Disc Replacement | – | Device: CerPass® Total Disc Replacement |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Volunteers will be selected from the surgeon's existing clinic patients.
Key inclusion criteria (10 listed)
- Age: 18-60 years of age (inclusive and skeletally mature);
- A diagnosis of symptomatic cervical disc disease, defined as image-confirmed pathology: herniated disc, spondylosis, and/or loss of disc height. Spondylosis is defined as image-confirmed disc desiccation, loss of disc height, bridging osteophytes, and/or uncovertebral arthrosis. Loss of disc height is specified as a measurement of at least 25 degrees less than an adjacent nonsymptomatic level, but with a minimum of 1mm height remaining;
- Functional neurological deficit (i.e., exhibits at least one sign associated with cervical level to be treated, including abnormal reflex, decreased motor strength, abnormal dermatome sensitivity, or pain in a dermatomal distribution);
- Symptomatic level is C3-4, C4-5, C5-6 or C6-7 (one level);
- Preoperative Neck Disability Index (NDI) greater than 30 points (considered moderate disability; Vernon 1991);
Key exclusion criteria (27 listed)
- Patients with the following characteristics will not be eligible for entry into the proposed study:
- Prior cervical fusion, prior laminectomy (prior cervical laminotomy that has not violated the facets need not be excluded), and/or prior cervical facetectomy at the operative level;
- Requiring surgical treatment that would leave the patient with a postoperative deficiency of the posterior elements;
- Signal changes in the cord on preoperative T2-weighted MRI and/or clinically significant myelopathy which would be described as gait disturbance, loss of manual dexterity, or bowel or bladder incontinence/retention.
- Radiographic signs of significant instability at operative level (greater than 3mm translation, greater than 11 degree rotation different from adjacent 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 |
|---|---|---|
| CerPass® Total Disc ReplacementSingle level cervical disc disease | Device | CerPass® Total Disc Replacement |
Primary outcome
The primary endpoints will be individual patient success at 24 months.
Time frame: 24 months
Success is defined as: Improvement in the Neck Disability Index (NDI) by ≥ 15 points at 24 months compared to Baseline; No device failures requiring revision, re-operation (including supplemental fixation), or removal from the patient; Maintenance or improvement of neurologic status (based on sensory, motor, and reflex assessment scores and observational gait analysis).
4 secondary outcomes
Range of motion (ROM)
Time frame: 24 months
SF-36
Time frame: 24-months
VAS analog pain scale (VAS)
Time frame: 24-months
Disc height improvement
Time frame: 24-months
Results and safety
The study was stopped early (reason given: Marketing of CE marked device has been discontinued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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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.
Kelli Howell study director
NuVasive
1 site 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, run by NuVasive at 1 site in Mexico.
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 10 inclusion and 27 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: stopped early, as of the sponsor's last update on 24 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 1 site in Mexico. 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?
The study was stopped early (reason given: Marketing of CE marked device has been discontinued.). Results are not available in the source record.
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?
The primary endpoints will be individual patient success at 24 months. (time frame: 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 24 Dec 2025.