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Clinical Trials in Germany / NCT05035693
Recruiting Not applicable

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

NCT05035693 · tracked via the Priya Life Science Germany tracker
Sponsor
NGMedical GmbH
Phase
Not applicable
Started
2021-03-11
Last updated
2024-11-15

Condition(s) studied

DiscopathyHerniated Cervical DiscStenoses, SpinalRadiculopathy

Investigational drug(s) / intervention(s)

MOVE®-C

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Diagnosis of discopathy or disc hernia with radiculopathy or stenosis of the foramen and spinal canal, 2. documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated, 3. no surgical treatment regarding the planned index surgery within the last six weeks prior implantation, 4. unsuccessful conservative medical care regarding the indication within the last six weeks, 5. age ≥18 years, 6. patient must agree to fully participate in the clinical trial and give informed consent in writing, 7. patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1), 8. 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: 1. 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, 2. active systemic infection or infection at the operative site, 3. sustained osteoporotic fracture of the spine, hip or wrist, 4. spinal metastases, 5. known allergy to titanium or polycarbonate-urethane, 6. confirmed pregnancy, 7. severe cervical myelopathy, 8. patients requiring a treatment that destabilises the spine (e.g. posterior element decompression), 9. advanced cervical anatomical deformity at the operative site (e.g. ankylosing spondylitis, scoliosis), 10. advanced degenerative changes (e.g. spondylosis) at the index vertebral level, 11. patient is kept in an institution under judicial or official orders (MPG §20.3).

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Wiener Gesundheitsverbund-Klinik Penzing Vienna Austria Recruiting
DRK Klinikum Berlin Berlin Germany Recruiting
Wirbelsäulenzentrum Fulda Main, Kinzig Gelnhausen Germany Recruiting
Medizinisches Versorgungszentrum Steinburg Itzehoe Germany Recruiting
Katholisches Klinikum Koblenz - Montabaur Koblenz Germany Recruiting
Neurochirurgie am Gasteig München Germany Recruiting
Rhein-Maas Klinikum Würselen Würselen Germany Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05035693 on ClinicalTrials.gov ↗ ← All trials in Germany