Clinical trial NCT02924506: Cervical Arthroplasty "Fixed Core" Versus "Movable Core": Clinical and Radiological Impact in the Medium Term
Official title: Cervical Arthroplasty "Fixed Core" Versus "Movable Core": A Controlled Prospective Study, Clinical and Radiological Impact in the Medium Term
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neck Pain
Back Pain
Keywords: cervical arthroplasty
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Neck Pain and Disability Scale (NPDS) between the two groups
timeFrame: Baseline
measure: Neck Pain and Disability Scale (NPDS) between the two groups
timeFrame: 3 months
measure: Neck Pain and Disability Scale (NPDS) between the two groups
timeFrame: 1 year
measure: Neck Pain and Disability Scale (NPDS) between the two groups
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Orleans
country: France
facility: CHR d'ORLEANS
city: Tours
country: France
facility: Hôpital Bretonneau, CHU DE TOURS
Study officials:
affiliation: CHR d'Orleans
name: Thierry DUFOUR, Ph
role: PRINCIPAL_INVESTIGATOR
References: