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Arthroplasty Versus Fusion in Anterior Cervical Surgery: Prospective Study of the Impact on the Adjacent Level

NCT00554528 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-09-30

No results posted yet for this study

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.

Conditions

  • Clinical Radiculopathy
  • Myelopathy Due to a Cervical Disk Disease

Interventions

DEVICE

cervical disc prosthesis with a mobile insert named Mobi-C

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

PROCEDURE

arthrodesis - cervical disk surgery

discectomy and arthrodesis

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Stephane LITRICO, Dr · Centre Hospitalier Universitaire de Nice

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • France

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 NCT00554528 on ClinicalTrials.gov