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Study halted prematurely and will not resume; participants are no longer receiving intervention due to coronavirus pandemic and unexpected enrollment delays.
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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).
PEEK: Polyetheretherketone ACDF: Anterior cervical discectomy and fusion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NanoMetalene/PEEK | Other |
| |
| NanoMetalene/Allograft | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior cervical discectomy and fusion | Procedure | primary, 2-level, contiguous |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 CT Analysis: Allograft |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khalid Abbed, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Brain and Spine | Phoenix | Arizona | 85013 | United States | ||
| University of California, San Diego |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 30, 2023 | |
| Reset | Jan 5, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 30, 2023 | Jan 5, 2024 |
| ID | Term |
|---|---|
| D050939 | Gene Fusion |
| ID | Term |
|---|---|
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
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Proportion of cervical spinal levels for NanoMetalene vs Allograft implants that have achieved fusion as determined by Computed Tomography (CT) analysis
| 12 months |
| 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 |
| 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 |
| 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 |
| 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 |
| La Jolla |
| California |
| 92093 |
| United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| UCLA Health | Santa Monica | California | 90401 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Spine Colorado | Durango | Colorado | 81301 | United States |
| Emory | Atlanta | Georgia | 30324 | United States |
| Hughston Clinic | Columbus | Georgia | 31909 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| OrthIndy | Indianapolis | Indiana | 46278 | United States |
| Henry Ford | Jackson | Michigan | 49201 | United States |