Clinical trial NCT03871400: The NanoStrand Clinical Study
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Disc Degeneration;Cervical
Lead sponsor: SeaSpine, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 cervical degenerative disc disease (DDD).

Detailed description: PEEK: Polyetheretherketone ACDF: Anterior cervical discectomy and fusion

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
timeFrame: 12 months
Secondary outcomes:
measure: Secondary CT Analysis: PEEK
timeFrame: 12 months
measure: Secondary CT Analysis: Allograft
timeFrame: 12 months
measure: Secondary X-Ray Analysis
timeFrame: 24 months
measure: Clinical Outcomes: NDI
timeFrame: 24 months
measure: Clinical Outcomes: VAS Arm
timeFrame: 24 months
measure: Clinical Outcomes: VAS Neck
timeFrame: 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Brain and Spine
state: Arizona
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Santa Monica
country: United States
facility: UCLA Health
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Durango
country: United States
facility: Spine Colorado
state: Colorado
city: Atlanta
country: United States
facility: Emory
state: Georgia
city: Columbus
country: United States
facility: Hughston Clinic
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: OrthIndy
state: Indiana
city: Jackson
country: United States
facility: Henry Ford
state: Michigan
Study officials:
affiliation: Yale University
name: Khalid Abbed, MD
role: PRINCIPAL_INVESTIGATOR
References: