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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
18
primary, 2-level, contiguous
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
Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
Time frame: 12 months
Secondary CT Analysis: PEEK
Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
Time frame: 12 months
Secondary CT Analysis: Allograft
Proportion of cervical spinal levels for NanoMetalene vs Allograft implants that have achieved fusion as determined by Computed Tomography (CT) analysis
Time frame: 12 months
Secondary X-Ray Analysis
Proportion of cervical spinal levels for NanoMetalene vs PEEK and Allograft implants that have achieved fusion as determined by x-ray analysis
Time frame: 24 months
Clinical Outcomes: NDI
Improvement of clinical outcomes (NDI) for all enrolled patients. Improvement is a reduction of scores for all clinical outcomes. Results will be shown as change from baseline to 24 month follow-up. The NDI is an index derived from the Neck Disability Index Pain Questionnaire used by surgeons, clinicians and researchers to quantify disability for neck pain. Scores are from 0-100 and a lower score represents a better score.
Time frame: 24 months
Clinical Outcomes: VAS Arm
Improvement of clinical outcomes (VAS Arm) for all enrolled patients. Improvement is a reduction of scores for all clinical outcomes. Results will be shown as change from baseline to 24 month follow-up. The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "0"/no pain at all" and "100/worst pain imaginable." The study in this scale is used for the worst arm pain. A lower score represents a better score.
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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
...and 1 more locations
Time frame: 24 months
Clinical Outcomes: VAS Neck
Improvement of clinical outcomes (VAS Neck) for all enrolled patients. Improvement is a reduction of scores for all clinical outcomes. Results will be shown as change from baseline to 24 month follow-up. The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "0"/no pain at all" and "100/worst pain imaginable." The study in this scale is used for neck pain. A lower score represents a better score.
Time frame: 24 months