Disc Degeneration;Cervical Clinical Trial
Official title:
Comparison of Early Fusion Using a NanoMetalene® Implant Versus Both PEEK and Allograft Implants in Anterior Cervical Discectomy and Fusion (ACDF) With OsteoStrand™ Demineralized Bone Fibers
| Verified date | October 2020 |
| Source | SeaSpine, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Suspended |
| Enrollment | 18 |
| Est. completion date | January 30, 2021 |
| Est. primary completion date | June 15, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory | Atlanta | Georgia |
| United States | University of Colorado Hospital | Aurora | Colorado |
| United States | Northwestern University | Chicago | Illinois |
| United States | Hughston Clinic | Columbus | Georgia |
| United States | Spine Colorado | Durango | Colorado |
| United States | OrthIndy | Indianapolis | Indiana |
| United States | Henry Ford | Jackson | Michigan |
| United States | University of California, San Diego | La Jolla | California |
| United States | University of Southern California | Los Angeles | California |
| United States | Barrow Brain and Spine | Phoenix | Arizona |
| United States | UCLA Health | Santa Monica | California |
| Lead Sponsor | Collaborator |
|---|---|
| SeaSpine, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis | Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis | 12 months | |
| Secondary | Secondary CT Analysis: PEEK | Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis | 12 months | |
| Secondary | Secondary CT Analysis: Allograft | Proportion of cervical spinal levels for NanoMetalene vs Allograft implants that have achieved fusion as determined by Computed Tomography (CT) analysis | 12 months | |
| Secondary | Secondary X-Ray Analysis | Proportion of cervical spinal levels for NanoMetalene vs PEEK and Allograft implants that have achieved fusion as determined by x-ray analysis | 24 months | |
| Secondary | Clinical Outcomes: NDI | 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. |
24 months | |
| Secondary | Clinical Outcomes: VAS Arm | 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. |
24 months | |
| Secondary | Clinical Outcomes: VAS Neck | 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. |
24 months |