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.
Who can participate
Age range18 Years
SexALL
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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
✕. 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,
What they're measuring
1
Improvement from baseline on Neck Disability Index (NDI)
Timeframe: Baseline and month 24
2
Improvement from baseline on Visual Analogue Scales (VAS arm/neck)