DRKS00022971RecruitingNot Applicable
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 sites170 target enrollmentStarted: January 8, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 170
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
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