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A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Cervical Disc Disease at 2 Contiguous Levels

NCT04564885 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-03-08

No results posted yet for this study

Summary

The proposed investigation is a multi-center, prospective, randomized, controlled comparison of the BAGUERA®C to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD) at two contiguous levels. Subjects will be randomized in a 2:1 ratio to the two-level BAGUERA®C Cervical Disc Prosthesis (investigational group) or to the two-level Mobi-C® Cervical Disc (control group). Subjects enrolled in the study will be evaluated pre-operatively, at the time of surgery, discharge, and at 6 weeks, 3, 6, 12, and 24 months and then annually until 7 years post-surgery.

Conditions

  • Cervical Disc Disease

Interventions

DEVICE

BAGUERA®C Cervical Disc Prosthesis

surgery

DEVICE

Mobi-C Cervical Disc

surgery

Sponsors & Collaborators

  • Spineart USA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2025-04-30
Completion
2030-04-30
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 NCT04564885 on ClinicalTrials.gov