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The NanoStrand Clinical Study

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ClinicalTrials.gov Identifier: NCT03871400
Recruitment Status : Suspended (Study halted prematurely and will not resume; participants are no longer receiving intervention due to coronavirus pandemic and unexpected enrollment delays.)
First Posted : March 12, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Disc Degeneration;Cervical Procedure: Anterior cervical discectomy and fusion Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : November 18, 2018
Actual Primary Completion Date : June 15, 2020
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
NanoMetalene/PEEK Procedure: Anterior cervical discectomy and fusion
primary, 2-level, contiguous

NanoMetalene/Allograft Procedure: Anterior cervical discectomy and fusion
primary, 2-level, contiguous




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.


  5. 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.


  6. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871400


Locations
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United States, Arizona
Barrow Brain and Spine
Phoenix, Arizona, United States, 85013
United States, California
University of California, San Diego
La Jolla, California, United States, 92093
University of Southern California
Los Angeles, California, United States, 90033
UCLA Health
Santa Monica, California, United States, 90401
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Spine Colorado
Durango, Colorado, United States, 81301
United States, Georgia
Emory
Atlanta, Georgia, United States, 30324
Hughston Clinic
Columbus, Georgia, United States, 31909
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
OrthIndy
Indianapolis, Indiana, United States, 46278
United States, Michigan
Henry Ford
Jackson, Michigan, United States, 49201
Sponsors and Collaborators
SeaSpine, Inc.
Investigators
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Principal Investigator: Khalid Abbed, MD Yale University
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Responsible Party: SeaSpine, Inc.
ClinicalTrials.gov Identifier: NCT03871400    
Other Study ID Numbers: SS-NM-1801
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases