The NanoStrand Clinical Study

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Conditions studied: Disc Degeneration;Cervical

In brief

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).

Key facts

Study ID

NCT03871400

Run by

SeaSpine, Inc.

People needed

18

Starts

2018-11-18

Expected to finish

2021-01-30

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify 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

Where it is running

• Barrow Brain and Spine — Phoenix, Arizona, United States
• University of California, San Diego — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• UCLA Health — Santa Monica, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Spine Colorado — Durango, Colorado, United States
• Emory — Atlanta, Georgia, United States
• Hughston Clinic — Columbus, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• OrthIndy — Indianapolis, Indiana, United States
• Henry Ford — Jackson, Michigan, United States

Full record on ClinicalTrials.gov

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