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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02924506

Acronym

DISC-C

Enrollment

Registered

2016-10-05

Start date

2015-02-19

Completion date

2018-11-30

Last updated

2019-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain, Neck Pain

Keywords

cervical arthroplasty

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.

Interventions

DEVICEMobi-C prothesis

Mobi-C Prothesis, LDR Medical (company)

DEVICEProDisc-C prothesis

ProDisc-C prothesis, Vivo Depuy Synthes (company)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Neck Pain and Disability Scale (NPDS) between the two groups	Baseline

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026