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

• Sponsor: Centre Hospitalier Régional d'Orléans (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02924506
• Collaborator: (none)
• Enrollment: 37
• Locations: 2
• Arms: 2
• Actual Duration (Months): 45.3
• Patients Per Site: 18.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neck Pain; Back Pain	Device: Mobi-C prothesis; Device: ProDisc-C prothesis	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Cervical Arthroplasty "Fixed Core" Versus "Movable Core": A Controlled Prospective Study, Clinical and Radiological Impact in the Medium Term
• Actual Study Start Date: Feb 19, 2015
• Actual Primary Completion Date: Nov 21, 2016
• Actual Study Completion Date: Nov 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Fixed Core Cervical arthroplasty with fixed core prothesis	Device: ProDisc-C prothesis; ProDisc-C prothesis, Vivo Depuy Synthes (company)
Other: Movable Core Cervical arthroplasty with movable core prothesis	Device: Mobi-C prothesis; Mobi-C Prothesis, LDR Medical (company)

Outcome Measures

Primary Outcome Measures

1. Neck Pain and Disability Scale (NPDS) between the two groups [Baseline]

2. Neck Pain and Disability Scale (NPDS) between the two groups [3 months]

3. Neck Pain and Disability Scale (NPDS) between the two groups [1 year]

4. Neck Pain and Disability Scale (NPDS) between the two groups [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHR d'ORLEANS	Orleans		France	45067
2	Hôpital Bretonneau, CHU DE TOURS	Tours		France	37044

Sponsors and Collaborators

• Centre Hospitalier Régional d'Orléans

Investigators

• Principal Investigator: Thierry DUFOUR, Ph, CHR d'Orleans

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Régional d'Orléans
• ClinicalTrials.gov Identifier: NCT02924506
• Other Study ID Numbers: CHRO-2014-04
• First Posted: Oct 5, 2016
• Last Update Posted: May 7, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Centre Hospitalier Régional d'Orléans: cervical arthroplasty
• Additional relevant MeSH terms: Neck Pain; Meloxicam

Study Results

No Results Posted as of May 7, 2019