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

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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).

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
Medford, Oregon 97504
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Medford, OR
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Durango, Colorado 81301
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Durango, CO
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Jackson, Michigan 49201
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Jackson, MI
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