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

Not Applicable

Terminated

• Conditions: Neck Pain; Back Pain
• Interventions: Device: ProDisc-C prothesis; Device: Mobi-C prothesis

• Registration Number: NCT02924506
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-19
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-05
• Primary Completion: 2016-11-21
• Study Completion: 2018-11-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed Core	ProDisc-C prothesis	Cervical arthroplasty with fixed core prothesis
Movable Core	Mobi-C prothesis	Cervical arthroplasty with movable core prothesis

Primary Outcome Measures

Name	Time	Method
Neck Pain and Disability Scale (NPDS) between the two groups	2 years

Trial Locations

Locations (2)

CHR d'ORLEANS; 🇫🇷 Orleans, France

Hôpital Bretonneau, CHU DE TOURS; 🇫🇷 Tours, France