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

Centre Hospitalier Régional d'Orléans

Status: Terminated

Conditions: Back Pain; Neck Pain

Treatments: Device: ProDisc-C prothesis; Device: Mobi-C prothesis

Study type: Interventional

Funder types: Other

Identifiers

NCT02924506

CHRO-2014-04

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 2 patient groups

Fixed Core

Other group

Description:

Cervical arthroplasty with fixed core prothesis

Treatment:

Device: ProDisc-C prothesis

Movable Core

Other group

Description:

Cervical arthroplasty with movable core prothesis

Treatment:

Device: Mobi-C prothesis