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

Recruiting now · Not applicable

Conditions studied: Discopathy, Herniated Cervical Disc, Stenoses, Spinal, Radiculopathy

In brief

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.

Key facts

Study ID

NCT05035693

Run by

NGMedical GmbH

People needed

170

Starts

2021-03-11

Expected to finish

2027-03-11

Last updated by the study team

2024-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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