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

NCT02924506 | Terminated

• 1 other identifier: CHRO-2014-04
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Neck Pain; Back Pain

Keywords

cervical arthroplasty

Outcome Measures

Primary Outcomes (4)

• Neck Pain and Disability Scale (NPDS) between the two groups

  Baseline

• Neck Pain and Disability Scale (NPDS) between the two groups

  3 months

• Neck Pain and Disability Scale (NPDS) between the two groups

  1 year

• Neck Pain and Disability Scale (NPDS) between the two groups

  2 years

Study Arms (2)

Fixed Core

OTHER

Cervical arthroplasty with fixed core prothesis

Device: ProDisc-C prothesis

Movable Core

OTHER

Cervical arthroplasty with movable core prothesis

Device: Mobi-C prothesis

Interventions

Mobi-C prothesis DEVICE

Mobi-C Prothesis, LDR Medical (company)

Movable Core

ProDisc-C prothesis DEVICE

ProDisc-C prothesis, Vivo Depuy Synthes (company)

Fixed Core

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 mental illness or disability involving a "safeguard procedure justice of the person"
• Contraindications to non steroidal anti inflammatory

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (2)

CHR d'ORLEANS

Orléans, 45067, France

Location

Hôpital Bretonneau, CHU DE TOURS

Tours, 37044, France

Location

MeSH Terms

Conditions

Neck Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thierry DUFOUR, Ph

  CHR d'Orleans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 5, 2016
• Study Start: February 19, 2015
• Primary Completion: November 21, 2016
• Study Completion: November 30, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)