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
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring cervical arthroplasty
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
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
NCT ID
NCT02924506
First Posted
October 3, 2016
Last Updated
May 3, 2019
Sponsor
Centre Hospitalier Régional d'Orléans
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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