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

This study has been terminated.
(Marketing of CE marked device has been discontinued.)
Sponsor:
Information provided by (Responsible Party):
NuVasive
ClinicalTrials.gov Identifier:
NCT01433367
First received: June 10, 2011
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Cervical Disc Disease
Device: CerPass® Total Disc Replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study Evaluating the Performance of the CerPass® Total Disc Replacement in Patients With Single-Level Cervical Disc Disease

Further study details as provided by NuVasive:

Primary Outcome Measures:
  • The primary endpoints will be individual patient success at 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

    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).



Secondary Outcome Measures:
  • Range of motion (ROM) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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."

  • SF-36 [ Time Frame: 24-months ] [ Designated as safety issue: No ]
    SF-36 improvement of 15% at 24 months compared to Baseline

  • VAS analog pain scale (VAS) [ Time Frame: 24-months ] [ Designated as safety issue: No ]
    Visual analog pain scale (VAS) improvement of 20 mm at 24 months compared to Baseline

  • Disc height improvement [ Time Frame: 24-months ] [ Designated as safety issue: No ]
    Disc height from the lateral radiograph showing maintenance or improvement from baseline at 24 months.


Enrollment: 2
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CerPass® Total Disc Replacement Device: CerPass® Total Disc Replacement
Single level cervical disc disease

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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);
  10. Endocrine disorders or connective tissue diseases;
  11. Rheumatoid arthritis or other autoimmune disease;
  12. Progressive neuromuscular disease, e.g., muscular dystrophy, multiple sclerosis;
  13. Chronic steroid users;
  14. 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;
  15. 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);
  16. Diabetes mellitus requiring insulin management;
  17. Presence of metastases or active spinal tumor malignancy;
  18. Body Mass Index (BMI) > 40;
  19. Active local or systemic infection, including AIDS, hepatitis;
  20. Having been enrolled in another investigational device study within the last 90 days;
  21. Having had another cervical device implanted that would interfere with the surgical approach, study or control device, or follow-up evaluations;
  22. Demonstrates 3 or more signs of nonorganic behavior, such as Waddell's signs;
  23. History of substance abuse;
  24. Involved in spinal litigation;
  25. Mentally incompetent;
  26. Incarcerated.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433367

Locations
Mexico
Hospital Del Prado
Tijuana, Baja California, Mexico
Sponsors and Collaborators
NuVasive
  More Information

No publications provided

Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT01433367     History of Changes
Other Study ID Numbers: NUVA-CP-0904
Study First Received: June 10, 2011
Last Updated: March 26, 2012
Health Authority: Venezuela: Ethics Committee

Keywords provided by NuVasive:
total disc replacement
cervical disc disease

Additional relevant MeSH terms:
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 24, 2014