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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neck Pain, Back Pain

Intervention / Treatment
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* Device: Mobi-C prothesis
* Device: ProDisc-C prothesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical arthroplasty