The NanoStrand Clinical Study
- Conditions
- Disc Degeneration;Cervical
- Interventions
- Procedure: Anterior cervical discectomy and fusion
- Registration Number
- NCT03871400
- Lead Sponsor
- SeaSpine, Inc.
- 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
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 18
- Cervical degenerative disc disease
- Requires primary spinal fusion from C3-C7
- Minimum of 6 weeks of non-operative treatment
- Signed informed consent form
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NanoMetalene/Allograft Anterior cervical discectomy and fusion - NanoMetalene/PEEK Anterior cervical discectomy and fusion -
- Primary Outcome Measures
Name Time Method Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis 12 months Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
- Secondary Outcome Measures
Name Time Method Secondary CT Analysis: PEEK 12 months Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
Secondary CT Analysis: Allograft 12 months Proportion of cervical spinal levels for NanoMetalene vs Allograft implants that have achieved fusion as determined by Computed Tomography (CT) analysis
Secondary X-Ray Analysis 24 months Proportion of cervical spinal levels for NanoMetalene vs PEEK and Allograft implants that have achieved fusion as determined by x-ray analysis
Clinical Outcomes: NDI 24 months 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.Clinical Outcomes: VAS Arm 24 months 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.Clinical Outcomes: VAS Neck 24 months 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.
Trial Locations
- Locations (11)
Northwestern University
🇺🇸Chicago, Illinois, United States
Barrow Brain and Spine
🇺🇸Phoenix, Arizona, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Spine Colorado
🇺🇸Durango, Colorado, United States
University of Southern California
🇺🇸Los Angeles, California, United States
UCLA Health
🇺🇸Santa Monica, California, United States
Emory
🇺🇸Atlanta, Georgia, United States
OrthIndy
🇺🇸Indianapolis, Indiana, United States
Henry Ford
🇺🇸Jackson, Michigan, United States
Hughston Clinic
🇺🇸Columbus, Georgia, United States