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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-19

Study Completion Date

2018-11-30

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.

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Detailed Description

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Conditions

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Neck Pain Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Fixed Core

Cervical arthroplasty with fixed core prothesis

Group Type OTHER

ProDisc-C prothesis

Intervention Type DEVICE

ProDisc-C prothesis, Vivo Depuy Synthes (company)

Movable Core

Cervical arthroplasty with movable core prothesis

Group Type OTHER

Mobi-C prothesis

Intervention Type DEVICE

Mobi-C Prothesis, LDR Medical (company)

Interventions

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Mobi-C prothesis

Mobi-C Prothesis, LDR Medical (company)

Intervention Type DEVICE

ProDisc-C prothesis

ProDisc-C prothesis, Vivo Depuy Synthes (company)

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No