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Triadyme-C, a Polycrystalline Diamond Compact Cervical Disc Replacement (cTDR)

NCT02967575 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2018-11-29

No results posted yet for this study

Summary

This Post Market Clinical Follow-up (PMCF) is conducted to collect clinical and radiographic outcome information on patients suffering from intractable symptomatic cervical disc disease requiring 1- or 2-level reconstruction of the disc from C3-C7, after being treated with the Triadyme-C polycrystalline diamond compact cervical disc replacement.

Conditions

  • Intervertebral Disc Disorder Cervical

Interventions

DEVICE

cTDR

The surgical procedure for the Triadyme-C total disc replacement corresponds to the standard surgical technique for cTDR: * Implantation through a standard anterior cervical approach * Midline identification * Routine discectomy with endplate preparation and decompression * Implant sizing and trial implantation * Keel preparation * Implant preparation and loading of the appropriate Triadyme-C implant * Triadyme-C insertion, positioned as close to the midline as possible

Sponsors & Collaborators

  • Dymicron EU GmbH

    lead INDUSTRY

Principal Investigators

  • Jan Spiller, MD · Stenum Ortho GmbH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2020-05-31
Completion
2020-10-31

Countries

  • Germany

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 NCT02967575 on ClinicalTrials.gov