PMCF MOVE®-CInternational, prospective, multicentre, non-randomised post-market clinical follow-up studyClinical and radiological outcome after mono- and bisegmental cervical intervertebral disc prosthetics - PMCF MOVE®-C

GMedical GmbH0 个研究点目标入组 170 人开始时间: 2021年1月8日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Patients must meet the following 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. The 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

•MOVE®-C should not be implanted in patients with the following conditions:
•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)

发起方

GMedical GmbH