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2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C

NCT04012996 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2025-07-30

No results posted yet for this study

Summary

A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).

Conditions

  • Symptomatic Cervical Disc Disease

Interventions

DEVICE

prodisc C SK and/or Vivo

Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).

DEVICE

Mobi-C Cervical Disc

Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).

Sponsors & Collaborators

  • Centinel Spine

    lead INDUSTRY

Principal Investigators

  • James Kuras · Centinel Spine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-05
Primary Completion
2025-08-31
Completion
2028-05-13
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 NCT04012996 on ClinicalTrials.gov