Menu
Recruiting NCT05035693

Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C

No phase Interventional Discopathy Herniated Cervical Disc Stenoses, Spinal Radiculopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MOVE®-C.
Who it may be relevant to
Registry conditions: Discopathy, Herniated Cervical Disc, Stenoses, Spinal, Radiculopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

"PMCF MOVE®-C" International, Prospective, Multicentre, Non-randomised Post-market Clinical Follow-up Study Clinical and Radiological Outcome After Mono- and Bisegmental Cervical Intervertebral Disc Prosthetics

Overview

Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG. Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.

Detailed description

This clinical investigation is conducted to gain post market results on the Cervical Disc Prosthesis MOVE®-C and to demonstrate the safety and performance. Besides, it is aimed to gain knowledge concerning the development of patients' quality of life (QoL) after the implantation of the Cervical Disc Prosthesis MOVE®-C and to collect data for the analysis of the range of motion (ROM), which is an essential parameter for motion-preserving implants.

Interventions

  • Device MOVE®-C
    Momo- or bisegmental implantation of MOVE®-C cervical prothesis.

Primary outcome measures

  • Improvement from baseline on Neck Disability Index (NDI) [Time frame: Baseline and month 24]
  • Improvement from baseline on Visual Analogue Scales (VAS arm/neck) [Time frame: Baseline and month 24]
Secondary outcome measures (6)
  • Change from baseline in Core Outcome Measure Index (COMI neck) [Time frame: Baseline and months 24]
  • Change from baseline in Short Form 36 Health Survey Questionnaire (SF-36) [Time frame: Baseline and moths 24]
  • Change from baseline in EuroQoL (EQ-5D-5L) [Time frame: Baseline and moths 24]
  • Change from baseline in Japanese Orthopedic Association Score (JOA) [Time frame: Baseline and moths 24]
  • Analyse of the Range of Motion (ROM) [Time frame: Baseline and moths 24]
  • Monitoring of product related occurence of adverse events (AE-Monitoring) [Time frame: Baseline and moths 24]

Eligibility criteria

Inclusion criteria

  • Diagnosis of discopathy or disc hernia with radiculopathy or stenosis of the foramen and spinal canal,
  • documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated,
  • no surgical treatment regarding the planned index surgery within the last six weeks prior implantation,
  • unsuccessful conservative medical care regarding the indication within the last six weeks,
  • age ≥18 years,
  • patient must agree to fully participate in the clinical trial and give informed consent in writing,
  • patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1),
  • patient information has been provided and all written consents of the patient are available.

Exclusion criteria

  • Known contraindication against the use of cervical intervertebral disc prostheses in accordance with the manufacturer's instructions for use:
  • Bone mineral density with T-score ≤ -1.5 as determined by spine DXA if male ≥ 60 years of age or female ≥ 50 years of age,
  • active systemic infection or infection at the operative site,
  • sustained osteoporotic fracture of the spine, hip or wrist,
  • spinal metastases,
  • known allergy to titanium or polycarbonate-urethane,
  • confirmed pregnancy,
  • severe cervical myelopathy,
  • patients requiring a treatment that destabilises the spine (e.g. posterior element decompression),
  • advanced cervical anatomical deformity at the operative site (e.g. ankylosing spondylitis, scoliosis),
  • advanced degenerative changes (e.g. spondylosis) at the index vertebral level,
  • patient is kept in an institution under judicial or official orders (MPG §20.3).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 6 centers
  • DRK Klinikum Berlin — Berlin
  • Wirbelsäulenzentrum Fulda Main, Kinzig — Gelnhausen
  • Medizinisches Versorgungszentrum Steinburg — Itzehoe
  • Katholisches Klinikum Koblenz - Montabaur — Koblenz
  • Neurochirurgie am Gasteig — München
  • Rhein-Maas Klinikum Würselen — Würselen
Austria · 1 center
  • Wiener Gesundheitsverbund-Klinik Penzing — Vienna

Identifiers

NCT: NCT05035693 · P004 · DRKS00022971

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗