Status:
SUSPENDED
The NanoStrand Clinical Study
Lead Sponsor:
SeaSpine, Inc.
Conditions:
Disc Degeneration;Cervical
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
Detailed Description
PEEK: Polyetheretherketone ACDF: Anterior cervical discectomy and fusion
Eligibility Criteria
Inclusion
- Cervical degenerative disc disease
- Requires primary spinal fusion from C3-C7
- Minimum of 6 weeks of non-operative treatment
- Signed informed consent form
Exclusion
- 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
Key Trial Info
Start Date :
November 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03871400
Start Date
November 18 2018
End Date
January 30 2021
Last Update
October 19 2020
Active Locations (11)
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1
Barrow Brain and Spine
Phoenix, Arizona, United States, 85013
2
University of California, San Diego
La Jolla, California, United States, 92093
3
University of Southern California
Los Angeles, California, United States, 90033
4
UCLA Health
Santa Monica, California, United States, 90401