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

Neck Pain Clinical Trial

— DISC-C  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02924506
• Other study ID #: CHRO-2014-04
• Status: Terminated
• Phase: N/A
• Start date: February 19, 2015
• Est. completion date: November 30, 2018

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: November 30, 2018
• Est. primary completion date: November 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Neck Pain

Intervention

Device:
• Mobi-C prothesis
Mobi-C Prothesis, LDR Medical (company)
• ProDisc-C prothesis
ProDisc-C prothesis, Vivo Depuy Synthes (company)

Locations

Country	Name	City	State
France	CHR d'ORLEANS	Orleans
France	Hôpital Bretonneau, CHU DE TOURS	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Pain and Disability Scale (NPDS) between the two groups		Baseline
Primary	Neck Pain and Disability Scale (NPDS) between the two groups		3 months
Primary	Neck Pain and Disability Scale (NPDS) between the two groups		1 year
Primary	Neck Pain and Disability Scale (NPDS) between the two groups		2 years