Summary

for people ages 18-80 (full criteria)
healthy people welcome
at La Jolla, California and other locations
study started
estimated completion

Description

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).

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

Details

PEEK: Polyetheretherketone ACDF: Anterior cervical discectomy and fusion

Keywords

Disc Degeneration;Cervical Intervertebral Disc Degeneration Anterior cervical discectomy and fusion NanoMetalene/PEEK NanoMetalene/Allograft

Eligibility

You can join if…

Open to people ages 18-80

  • Cervical degenerative disc disease
  • Requires primary spinal fusion from C3-C7
  • Minimum of 6 weeks of non-operative treatment
  • Signed informed consent form

You CAN'T join if...

  • 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

Locations

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States
  • UCLA Health not yet accepting patients
    Santa Monica California 90401 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
SeaSpine, Inc.
ID
NCT03871400
Study Type
Interventional
Last Updated