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

Primary Purpose

Neck Pain, Back Pain

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mobi-C prothesis
ProDisc-C prothesis
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring cervical arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHR d'ORLEANS
  • Hôpital Bretonneau, CHU DE TOURS

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Fixed Core

Movable Core

Arm Description

Cervical arthroplasty with fixed core prothesis

Cervical arthroplasty with movable core prothesis

Outcomes

Primary Outcome Measures

Neck Pain and Disability Scale (NPDS) between the two groups
Neck Pain and Disability Scale (NPDS) between the two groups
Neck Pain and Disability Scale (NPDS) between the two groups
Neck Pain and Disability Scale (NPDS) between the two groups

Secondary Outcome Measures

Full Information

First Posted
October 3, 2016
Last Updated
May 3, 2019
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT02924506
Brief Title
Cervical Arthroplasty "Fixed Core" Versus "Movable Core": Clinical and Radiological Impact in the Medium Term
Acronym
DISC-C
Official Title
Cervical Arthroplasty "Fixed Core" Versus "Movable Core": A Controlled Prospective Study, Clinical and Radiological Impact in the Medium Term
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Moving of coordinator.
Study Start Date
February 19, 2015 (Actual)
Primary Completion Date
November 21, 2016 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Back Pain
Keywords
cervical arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fixed Core
Arm Type
Other
Arm Description
Cervical arthroplasty with fixed core prothesis
Arm Title
Movable Core
Arm Type
Other
Arm Description
Cervical arthroplasty with movable core prothesis
Intervention Type
Device
Intervention Name(s)
Mobi-C prothesis
Intervention Description
Mobi-C Prothesis, LDR Medical (company)
Intervention Type
Device
Intervention Name(s)
ProDisc-C prothesis
Intervention Description
ProDisc-C prothesis, Vivo Depuy Synthes (company)
Primary Outcome Measure Information:
Title
Neck Pain and Disability Scale (NPDS) between the two groups
Time Frame
Baseline
Title
Neck Pain and Disability Scale (NPDS) between the two groups
Time Frame
3 months
Title
Neck Pain and Disability Scale (NPDS) between the two groups
Time Frame
1 year
Title
Neck Pain and Disability Scale (NPDS) between the two groups
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry DUFOUR, Ph
Organizational Affiliation
CHR d'Orleans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'ORLEANS
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
Hôpital Bretonneau, CHU DE TOURS
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cervical Arthroplasty "Fixed Core" Versus "Movable Core": Clinical and Radiological Impact in the Medium Term

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