Back to resultsThe NanoStrand Clinical Study
Primary Purpose
Disc Degeneration;Cervical
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anterior cervical discectomy and fusion
Sponsored by
About this trial
This is an interventional other trial for Disc Degeneration;Cervical
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
Sites / Locations
- Barrow Brain and Spine
- University of California, San Diego
- University of Southern California
- UCLA Health
- University of Colorado Hospital
- Spine Colorado
- Emory
- Hughston Clinic
- Northwestern University
- OrthIndy
- Henry Ford
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
NanoMetalene/PEEK
NanoMetalene/Allograft
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03871400
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Suspended
Why Stopped
Study halted prematurely and will not resume; participants are no longer receiving intervention due to coronavirus pandemic and unexpected enrollment delays.
Study Start Date
November 18, 2018 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
January 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SeaSpine, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disc Degeneration;Cervical
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NanoMetalene/PEEK
Arm Type
Other
Arm Title
NanoMetalene/Allograft
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Anterior cervical discectomy and fusion
Intervention Description
primary, 2-level, contiguous
Primary Outcome Measure Information:
Title
Proportion of cervical spinal levels for NanoMetalene vs PEEK interbody implants that have achieved fusion as determined by Computed Tomography (CT) analysis
Description
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 Outcome Measure Information:
Title
Secondary CT Analysis: PEEK
Description
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
Title
Secondary CT Analysis: Allograft
Description
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
Title
Secondary X-Ray Analysis
Description
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
Title
Clinical Outcomes: NDI
Description
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
Title
Clinical Outcomes: VAS Arm
Description
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.
Time Frame
24 months
Title
Clinical Outcomes: VAS Neck
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid Abbed, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Brain and Spine
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA Health
City
Santa Monica
State/Province
California
ZIP/Postal Code
90401
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Spine Colorado
City
Durango
State/Province
Colorado
ZIP/Postal Code
81301
Country
United States
Facility Name
Emory
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30324
Country
United States
Facility Name
Hughston Clinic
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
OrthIndy
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46278
Country
United States
Facility Name
Henry Ford
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The NanoStrand Clinical Study
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