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Novum Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion

NCT03828136 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-04-07

No results posted yet for this study

Summary

A prospective, multicenter, randomized, concurrently controlled, noninferiority clinical trial to compare the safety and effectiveness of instrumented Bio2 Vitrium Cervical Interbody Device in anterior cervical discectomy and fusion (ACDF) with structural allograft bone and local autologous bone graft in treating patients with a symptomatic degenerative cervical disc disease at one level from C3/C4 to C7/T1.

Conditions

  • Symptomatic Cervical Disc Disease

Interventions

DEVICE

Novum Vitrium® Cervical Interbody Device

For spinal fusion procedure at one level (C3 to T1) of the cervical spine.

DEVICE

Allograft Ring or Block

Standard of Care

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Bio2 Technologies

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-24
Primary Completion
2022-03-21
Completion
2022-03-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03828136 on ClinicalTrials.gov