Phase
Condition
Radiculopathy
Spinal Stenosis
Spondylolisthesis
Treatment
MOVE®-C
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of discopathy or disc hernia with radiculopathy or stenosis of the foramenand spinal canal,
documented individual history of neck and/or upper extremity pain and/orfunctional/neurological deficit associated with the cervical level to be treated,
no surgical treatment regarding the planned index surgery within the last six weeksprior implantation,
unsuccessful conservative medical care regarding the indication within the last sixweeks,
age ≥18 years,
patient must agree to fully participate in the clinical trial and give informedconsent in writing,
patient is capable to realise the nature, aims and possible consequences of theclinical trial (MPG §20.2.1),
patient information has been provided and all written consents of the patient areavailable.
Exclusion
Exclusion Criteria:
- Known contraindication against the use of cervical intervertebral disc prostheses inaccordance 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. posteriorelement decompression),
advanced cervical anatomical deformity at the operative site (e.g. ankylosingspondylitis, 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).
Study Design
Study Description
Connect with a study center
Wiener Gesundheitsverbund-Klinik Penzing
Wien, 1180
AustriaActive - Recruiting
DRK Klinikum Berlin
Berlin, 14050
GermanyActive - Recruiting
Wirbelsäulenzentrum Fulda Main, Kinzig
Gelnhausen, 63571
GermanyActive - Recruiting
Medizinisches Versorgungszentrum Steinburg
Itzehoe, 25524
GermanyActive - Recruiting
Stätisches Klinikum Karlsruhe gGmbH
Karlsruhe, 76133
GermanySite Not Available
Katholisches Klinikum Koblenz - Montabaur
Koblenz, 56073
GermanyActive - Recruiting
Neurochirurgie am Gasteig
München, 81669
GermanyActive - Recruiting
Rhein-Maas Klinikum Würselen
Würselen, 52146
GermanyActive - Recruiting
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