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RHINE™ Cervical Disc Clinical Study: A Prospective Observational Study for Patients Requiring 1-2 Level C-spine Surgery

NCT02403453 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 68

Last updated 2023-10-25

No results posted yet for this study

Summary

A Prospective, open label, multi-center observational study of patients requiring surgical treatment at one or two (contiguous) cervical spine levels. The primary objectives of the RHINE Cervical Disc study are to: obtain operative data and feedback on surgical instruments and surgical technique; confirm device performance in terms of clinical and radiographic outcomes; confirm device performance in terms of safety and to collect original data to be compared to published reports of the performance of comparable motion-sparing devices, as well as clinical outcomes of fusion devices.

Conditions

  • Radiculopathy
  • Myelopathy
  • Spondylosis
  • Herniated Nucleus Pulposus

Interventions

DEVICE

Rhine Cervical Disc

RHINE Cervical Disc

Sponsors & Collaborators

  • Stryker Nordic

    collaborator INDUSTRY

  • K2M, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2023-03-31
Completion
2023-03-31

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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 NCT02403453 on ClinicalTrials.gov