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NCT01609374 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2019-09-18

No results posted yet for this study

Summary

This is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy with or without cord compression. Some participating sites will enroll just M6-C patients, while others will enroll just ACDF patients.

Patients eligible for study enrollment will present with degenerative cervical radiculopathy requiring surgical intervention, confirmed clinically and radiographically, at one vertebral level from C3 to C7.

A total of 243 subjects will be included at up to 20 sites.

Conditions

  • Cervical Radiculopathy
  • Degenerative Disc Disease

Interventions

DEVICE

M6-C Artificial Cervical Disc

Total disc replacement

DEVICE

Anterior plate system with corticocancellous allograft bone

Cervical fusion

Sponsors & Collaborators

  • Spinal Kinetics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2019-12-31
Completion
2019-12-31

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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 NCT01609374 on ClinicalTrials.gov