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A Clinical Trial Evaluating a Total Disc Replacement in Patients With Cervical Disc Disease | Clinical Trials | Clareo Health

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A Clinical Trial Evaluating a Total Disc Replacement in Patients With Cervical Disc Disease

A Prospective Observational Study Evaluating the Performance of the CerPass® Total Disc Replacement in Patients With Single-Level Cervical Disc Disease

NCT01433367•NuVasive

View on ClinicalTrials.gov

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 progressive neurological symptoms or signs in the face of conservative treatment.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The criteria for inclusion into the proposed clinical study are as follows:
•1. Age: 18-60 years of age (inclusive and skeletally mature);
•2. 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;
•3. 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);
•4. Symptomatic level is C3-4, C4-5, C5-6 or C6-7 (one level);
•5. Preoperative Neck Disability Index (NDI) greater than 30 points (considered moderate disability; Vernon 1991);
•6. 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;
•7. Not pregnant, nor interested in becoming pregnant within the follow-up period of the study;
•8. Willing and able to comply with the requirements defined in the protocol for the duration of the study;
•9. Signed and dated Informed Consent.

Exclusion Criteria

•Patients with the following characteristics will not be eligible for entry into the proposed study:
•1. 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;
•2. Requiring surgical treatment that would leave the patient with a postoperative deficiency of the posterior elements;
•3. 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.
•4. Radiographic signs of significant instability at operative level (greater than 3mm translation, greater than 11 degree rotation different from adjacent level);
•5. Bridging osteophytes or motion \< 3 degrees;
•6. Radiographic confirmation of significant facet joint disease or degeneration;
•7. Chronic neck or arm pain of unknown etiology;
•8. Cervical fracture, anatomic anomaly, or deformity (e.g. ankylosing spondylitis, scoliosis) at the levels to which the prosthesis will be attached;
•9. Severe spondylolisthesis (greater than grade 1);
+17 more criteria

Locations (1)

Hospital Del Prado

Tijuana, Estado de Baja California, Mexico

Key Dates

Start Date

May 1, 2010

Primary Completion Date

December 1, 2013

Completion Date

December 1, 2013

Last Updated

December 24, 2025

Enrollment

ACTUAL participants

Conditions

Cervical Disc Disease

Interventions

CerPass® Total Disc Replacement

DEVICE

Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion

NCT06601634

Neck PainCervical Spondylosis+1 more

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ENROLLING_BY_INVITATION

NuVasive® ACP System Study

NCT05066711

Cervical SpondylosisCervical Radiculopathy+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Trial Evaluating a Total Disc Replacement in Patients With Cervical Disc Disease

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