CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 599 enrolled
Drug / intervention
Cervical Artificial Discdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00389597
NCT00389597N/ACompleted
CompareCT.gov

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

LDR Spine USA·interventional·Posted Oct 19, 2006·Updated Dec 11, 2017

In Brief

A clinical study evaluating Cervical Artificial Disc for Degenerative Disc Disease. Completed, enrolled 599 participants across 24 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDegenerative Disc Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 19, 2006
Enrollment StartApr 1, 2006
Primary CompletionMar 1, 2010
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 19.7 years ago

Interventions

Cervical Artificial Discdevice

Cervical artificial disc mechanical device