The NanoStrand Clinical Study
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 3/14/2019 |
| Start Date: | November 18, 2018 |
| End Date: | June 2022 |
Comparison of Early Fusion Using the Cambria™ NanoMetalene® Implant Versus Both PEEK and Allograft Implants in ACDF With OsteoStrand™ Demineralized Bone Fibers
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).
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
Inclusion Criteria:
- Current nicotine use
- 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
- Pregnancy
- Participation in another research study
Exclusion Criteria:
- Infection of the operative site
- Use of implants from other systems
We found this trial at
3
sites
Click here to add this to my saved trials
Click here to add this to my saved trials