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A Multi-center Prospective Randomized Controlled Study on Clinical and Radiographic Analysis of ProDisc-C Vivo

NCT03367039 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 648

Last updated 2017-12-08

No results posted yet for this study

Summary

The object of this study is to assess the long-term safety and efficacy of cervical disc replacement with the ProDisc-C vivo Cervical Disc in a prospective, randomized, multi-center trial with 7 years of follow-up.

Conditions

  • Disk Degeneration
  • Cervical Disc Disease

Interventions

PROCEDURE

ProDisc-C vivo

Total Disc Replacement using ProDisc-C vivo.

PROCEDURE

Anterior cervical discectomy fusion

Anterior Cervical Discectomy and Fusion

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Zhenqi Zhu, Master · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2025-03-01
Completion
2025-03-01

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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 NCT03367039 on ClinicalTrials.gov