MedTrace Logo

Total Disc Replacement Versus Anterior Cervical Decompression and Fusion

NCT02417272 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2022-01-03

No results posted yet for this study

Summary

Background : Cervical degenerative disc disease is frequent and the consequence of aging. Degeneration may lead to disc herniation. Surgery is indicated in the presence of root compression with cervicobrachial neuralgia and/or myelopathy.

Purpose: The main objective of the study is the comparison of efficacy between total disc replacement (TDR) and Anterior Cervical Decompression and Fusion (ACDF) as surgical treatment of symptomatic cervical degenerative disc disease in term of "Success" rate, defined as preservation of adjacent segments, 24 months after surgery.

In our knowledge, there are no published data about randomized clinical trials comparing these radiological parameters (worsening of degeneration signs on static cervical spine radiographs and worsening of disc degeneration signs on MRI) at levels adjacent to surgery, between these 2 surgical approaches in patients suffering from cervical degenerative disc disease.

Conditions

  • Cervical Degenerative Disc Disease

Interventions

DEVICE

Surgical treatment of cervical degenerative disc disease (CP ESP®)

DEVICE

Surgical treatment of cervical degenerative disc disease (Axelle®)

Axelle®

Sponsors & Collaborators

  • Ministry for Health and Solidarity, France

    collaborator OTHER_GOV

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Antoine BENARD, MD · University Hospital Bordeaux, France

  • Olivier GILLE, Prof · University Hospital Bordeaux, France

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-11-04
Primary Completion
2021-11-24
Completion
2021-11-24

Countries

  • France

Study Locations

More Related Trials

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 NCT02417272 on ClinicalTrials.gov