NCT03871400

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).

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1.6 years

First QC Date

March 8, 2019

Last Update Submit

October 13, 2020

Conditions

Disc Degeneration;Cervical

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Secondary CT Analysis: PEEK

    12 months

  • Secondary CT Analysis: Allograft

    12 months

  • Secondary X-Ray Analysis

    24 months

  • Clinical Outcomes: NDI

    24 months

  • Clinical Outcomes: VAS Arm

    24 months

  • +1 more secondary outcomes

Study Arms (2)

NanoMetalene/PEEK

OTHER
Procedure: Anterior cervical discectomy and fusion

NanoMetalene/Allograft

OTHER
Procedure: Anterior cervical discectomy and fusion

Interventions

Anterior cervical discectomy and fusionPROCEDURE

primary, 2-level, contiguous

NanoMetalene/AllograftNanoMetalene/PEEK

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cervical degenerative disc disease
  • Requires primary spinal fusion from C3-C7
  • Minimum of 6 weeks of non-operative treatment
  • Signed informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Barrow Brain and Spine

Phoenix, Arizona, 85013, United States

Location

University of California, San Diego

La Jolla, California, 92093, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

UCLA Health

Santa Monica, California, 90401, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Spine Colorado

Durango, Colorado, 81301, United States

Location

Emory

Atlanta, Georgia, 30324, United States

Location

Hughston Clinic

Columbus, Georgia, 31909, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

OrthIndy

Indianapolis, Indiana, 46278, United States

Location

Henry Ford

Jackson, Michigan, 49201, United States

Location

MeSH Terms

Interventions

Gene Fusion

Intervention Hierarchy (Ancestors)

Recombination, GeneticGenetic Phenomena

Study Officials

  • Khalid Abbed, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 12, 2019

Study Start

November 18, 2018

Primary Completion

June 15, 2020

Study Completion

January 30, 2021

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(11)