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LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE

NCT00389597 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 599

Last updated 2017-12-11

Study results available
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Summary

The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C® Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device. The primary objective of the study is to evaluate the overall success rate of the investigational device as compared to the control in the treatment of patients with symptomatic DDD with radiculopathy or myeloradiculopathy at one or two adjacent levels. Patients should be without prior cervical fusion between C3 and C7 and unresponsive to non-operative conservative treatment for six weeks after symptom onset or have the presence of progressive symptoms or signs of nerve/spinal cord compression despite continued non-operative conservative treatment.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

Cervical Artificial Disc

Cervical artificial disc mechanical device

Sponsors & Collaborators

  • LDR Spine USA

    lead INDUSTRY

Principal Investigators

  • Ralph Rashbaum, MD · Texas Back Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2010-03-31
Completion
2015-11-30

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 NCT00389597 on ClinicalTrials.gov