Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C
"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
NGMedical GmbH
170 participants
Mar 11, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria12
- 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).
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Interventions
Momo- or bisegmental implantation of MOVE®-C cervical prothesis.
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT05035693