CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
cervical disc prosthesis with a mobile insert named Mobi-C +1 moredevice
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/NCT00554528
NCT00554528Phase 4Completed
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Arthroplasty Versus Fusion in Anterior Cervical Surgery: Prospective Study of the Impact on the Adjacent Level

Centre Hospitalier Universitaire de Nice·interventional·Posted Nov 7, 2007·Updated Sep 30, 2015

In Brief

A Phase 4 clinical trial evaluating cervical disc prosthesis with a mobile insert named Mobi-C and arthrodesis - cervical disk surgery for Clinical Radiculopathy and Myelopathy Due to a Cervical Disk Disease. Completed, enrolled 200 participants across 1 site.

Detailed Summary

The aim of the study is to evaluate the impact of the cervical disk surgery on the deterioration of the adjacent levels. The investigators compare the radiological deterioration of adjacent levels, at 3 years, in both situation of fusion and arthroplasty. 220 patients are enrolled and randomized to receive fusion or prosthesis. Radiological and clinical follow-up is organized for a period of 3 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClinical Radiculopathy, Myelopathy Due to a Cervical Disk Disease
CountriesFrance
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 7, 2007
Enrollment StartMay 1, 2007
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 18.7 years ago

Interventions

cervical disc prosthesis with a mobile insert named Mobi-Cdevice

Stage 1: partial discectomy stage 2: location of the medial axis stage 3: centering pin stage 4: installation of the caspar spacer stage 5: total discectomy stage 6: parallel distraction stage 7: depth measurement stage 8: trial implant stage 9: assembly stage 10: implant insertion stage 11: anchorage optimization

arthrodesis - cervical disk surgeryprocedure

discectomy and arthrodesis