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

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).

Study Overview

• Status: Suspended
• Conditions: Disc Degeneration;Cervical
• Intervention / Treatment: Procedure: Anterior cervical discectomy and fusion

Detailed Description

PEEK: Polyetheretherketone ACDF: Anterior cervical discectomy and fusion

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • 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: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NanoMetalene/PEEK	Procedure: Anterior cervical discectomy and fusion; primary, 2-level, contiguous
Other: NanoMetalene/Allograft	Procedure: Anterior cervical discectomy and fusion; 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	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	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	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	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	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	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	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: SeaSpine, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2018
• Primary Completion (Actual): June 15, 2020
• Study Completion (Anticipated): January 30, 2021

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: SS-NM-1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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