Cervical Arthroplasty "Fixed Core" Versus "Movable Core": Clinical and Radiological Impact in the Medium Term (DISC-C)

May 3, 2019 updated by: Centre Hospitalier Régional d'Orléans

Cervical Arthroplasty "Fixed Core" Versus "Movable Core": A Controlled Prospective Study, Clinical and Radiological Impact in the Medium Term

Nowadays, there is no clinical and radiological study comparing two different types of mobile implants in patients requiring surgical treatment for symptomatic cervical disc disease. Thus, the choice of the ideal implant remains uncertain.

The goal of this work is to compare the impact of two types of mobile implants in height drives, solicitation facets, positioning and collection of prostheses within the intervertebral spaces.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Orleans, France, 45067
        • Chr D'Orleans
      • Tours, France, 37044
        • Hôpital Bretonneau, CHU DE TOURS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years
  • Symptomatic cervical disc degenerative pathologies to 1 or more contiguous or non-contiguous levels C3-4 to C6-7.
  • Symptoms including: Cervicobrachial neuralgia and / or Loss of root muscle strength and / or Sensory impairment and paresthesia and / or Cervical myelopathy table
  • Concordant diagnosis confirmed by CT (Computerized Tomography scanner) and MRI (Magnetic Resonance Imaging) of the cervical spine
  • NPDS (Neck Pain and Disability Scale) > 30
  • Failure to respond to conservative medical treatment for 6 weeks or worsening symptoms despite conservative treatment
  • Physical and mental fitness to ensure compliance with the protocol
  • Signed informed consent

Exclusion Criteria:

  • Unstable cervical spine injuries requiring fusion C1 to C7 for whatever the etiology, proven on dynamic views of the cervical spine
  • Paget's disease, osteomalacia, other metabolic bone diseases
  • Chronic corticosteroid use
  • Active tumor pathology
  • Segmental angulation < -11 ° or > 11 ° at the respective segment or adjacent segments on static images of the cervical spine
  • Known allergy to Chromium, Cobalt, Mobdylene (chemical element), Polyethylene, or Titanium
  • History of surgery in the previous 30 days before inclusion
  • History of mental illness or disability involving a "safeguard procedure justice of the person"
  • Contraindications to non steroidal anti inflammatory

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fixed Core
Cervical arthroplasty with fixed core prothesis
Device: ProDisc-C prothesis
ProDisc-C prothesis, Vivo Depuy Synthes (company)
Other: Movable Core
Cervical arthroplasty with movable core prothesis
Device: Mobi-C prothesis
Mobi-C Prothesis, LDR Medical (company)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neck Pain and Disability Scale (NPDS) between the two groups
Time Frame: Baseline
Baseline
Neck Pain and Disability Scale (NPDS) between the two groups
Time Frame: 3 months
3 months
Neck Pain and Disability Scale (NPDS) between the two groups
Time Frame: 1 year
1 year
Neck Pain and Disability Scale (NPDS) between the two groups
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Thierry DUFOUR, Ph, Chr D'Orleans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2015

Primary Completion (Actual)

November 21, 2016

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRO-2014-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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