Degenerative Disc Disease Musculoskeletal Diseases Other intervertebral disc disorders
Conditions
Interventions
Cervical spinal reconstruction
Sponsors
Nuvasive Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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% 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) = 30 points (considered moderate disability; Vernon 1991); 6. Unresponsive to conservative treatment for = 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
Exclusion criteria: 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 (> 3mm translation, > 11° rotation different from adjacent level) 5. Bridging osteophytes or motion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Individual patient success at 24 months, tested using Blackwelder?s method for testing non-inferiority with delta of 10%. Success is defined as: 1. Improvement in the Neck Disability Index (NDI) by = 15 points at 24 months compared to Baseline 2. No device failures requiring revision, re-operation (including supplemental fixation), or removal from the patient 3. No device-related serious adverse event and 4. Maintenance or improvement of neurologic status (based on sensory, motor, and reflex assessment scores and observational gait analysis) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 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' 2. Fusion (defined as = 3° of ROM at the operative level, absence of radiolucent lines around = 50% of the implant, and no displacement or migration of the device (defined as > 3mm abnormal movement measured from AP and lateral plain films) 3. SF-36 improvement of = 15% at 24 months compared to Baseline 4. Visual analog pain scale (VAS) improvement of = 20 mm at 24 months compared to Baseline 5. Disc height from the lateral radiograph showing maintenance or improvement from Baseline at 24 months | — |
Countries
Mexico
Outcome results
None listed