Disc Degeneration;Cervical
Conditions
Brief summary
A prospective, multi-center, randomized, self-controlled, single-blinded, clinical study evaluating the NanoMetalene implant as compared to the PEEK and allograft implants in ACDF for the treatment of cervical degenerative disc disease (DDD).
Detailed description
PEEK: Polyetheretherketone ACDF: Anterior cervical discectomy and fusion
Interventions
primary, 2-level, contiguous
Sponsors
SeaSpine, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Cervical degenerative disc disease * Requires primary spinal fusion from C3-C7 * Minimum of 6 weeks of non-operative treatment * Signed informed consent form
Exclusion criteria
* Uncontrolled type I or II diabetes mellitus * Morbid obesity * Documented history of alcohol or drug abuse * Fever or leukocytosis * Current systemic infection * Active malignancy and/or current chemotherapy * Known history of osteoporosis * Prior fusion or total disc replacement at the operative level or an adjacent level * Infection of the operative site * Use of implants from other systems * Pregnancy * Participation in another research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis | 12 months | Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary CT Analysis: Allograft | 12 months | Proportion of cervical spinal levels for NanoMetalene vs Allograft implants that have achieved fusion as determined by Computed Tomography (CT) analysis |
| Secondary X-Ray Analysis | 24 months | Proportion of cervical spinal levels for NanoMetalene vs PEEK and Allograft implants that have achieved fusion as determined by x-ray analysis |
| Secondary CT Analysis: PEEK | 12 months | Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis |
| Clinical Outcomes: VAS Arm | 24 months | Improvement of clinical outcomes (VAS Arm) for all enrolled patients. Improvement is a reduction of scores for all clinical outcomes. Results will be shown as change from baseline to 24 month follow-up. The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 0/no pain at all and 100/worst pain imaginable. The study in this scale is used for the worst arm pain. A lower score represents a better score. |
| Clinical Outcomes: VAS Neck | 24 months | Improvement of clinical outcomes (VAS Neck) for all enrolled patients. Improvement is a reduction of scores for all clinical outcomes. Results will be shown as change from baseline to 24 month follow-up. The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 0/no pain at all and 100/worst pain imaginable. The study in this scale is used for neck pain. A lower score represents a better score. |
| Clinical Outcomes: NDI | 24 months | Improvement of clinical outcomes (NDI) for all enrolled patients. Improvement is a reduction of scores for all clinical outcomes. Results will be shown as change from baseline to 24 month follow-up. The NDI is an index derived from the Neck Disability Index Pain Questionnaire used by surgeons, clinicians and researchers to quantify disability for neck pain. Scores are from 0-100 and a lower score represents a better score. |
Countries
United States
Outcome results
None listed