- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03871400
The NanoStrand Clinical Study
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85013
- Barrow Brain and Spine
-
-
California
-
La Jolla, California, United States, 92093
- University of California, San Diego
-
Los Angeles, California, United States, 90033
- University of Southern California
-
Santa Monica, California, United States, 90401
- UCLA Health
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Hospital
-
Durango, Colorado, United States, 81301
- Spine Colorado
-
-
Georgia
-
Atlanta, Georgia, United States, 30324
- Emory
-
Columbus, Georgia, United States, 31909
- Hughston Clinic
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Indiana
-
Indianapolis, Indiana, United States, 46278
- OrthIndy
-
-
Michigan
-
Jackson, Michigan, United States, 49201
- Henry Ford
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: NanoMetalene/PEEK
|
primary, 2-level, contiguous
|
Other: NanoMetalene/Allograft
|
primary, 2-level, contiguous
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary CT Analysis: PEEK
Time Frame: 12 months
|
Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
|
12 months
|
Secondary CT Analysis: Allograft
Time Frame: 12 months
|
Proportion of cervical spinal levels for NanoMetalene vs Allograft implants that have achieved fusion as determined by Computed Tomography (CT) analysis
|
12 months
|
Secondary X-Ray Analysis
Time Frame: 24 months
|
Proportion of cervical spinal levels for NanoMetalene vs PEEK and Allograft implants that have achieved fusion as determined by x-ray analysis
|
24 months
|
Clinical Outcomes: NDI
Time Frame: 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. |
24 months
|
Clinical Outcomes: VAS Arm
Time Frame: 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. |
24 months
|
Clinical Outcomes: VAS Neck
Time Frame: 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. |
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SS-NM-1801
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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