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

NCT01433367 | Terminated

• 1 other identifier: NUVA-CP-0904
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Disc Disease

Keywords

total disc replacement; cervical disc disease

Outcome Measures

Primary Outcomes (1)

• 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).

  24 months

Secondary Outcomes (4)

• Range of motion (ROM)

  24 months

• SF-36

  24-months

• VAS analog pain scale (VAS)

  24-months

• Disc height improvement

  24-months

Study Arms (1)

CerPass® Total Disc Replacement

Device: CerPass® Total Disc Replacement

Interventions

CerPass® Total Disc Replacement DEVICE

Single level cervical disc disease

CerPass® Total Disc Replacement

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers will be selected from the surgeon's existing clinic patients.

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• NuVasive: lead

Study Sites (1)

Hospital Del Prado

Tijuana, Estado de Baja California, Mexico

Location

Study Officials

• Kelli Howell

  NuVasive

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2011
• First Posted: September 13, 2011
• Study Start: May 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

ME (1)