Status:
RECRUITING
Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C
Lead Sponsor:
NGMedical GmbH
Conditions:
Discopathy
Herniated Cervical Disc
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 cervica...
Detailed Description
This clinical investigation is conducted to gain post market results on the Cervical Disc Prosthesis MOVE®-C and to demonstrate the safety and performance. Besides, it is aimed to gain knowledge conce...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 11 2027
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT05035693
Start Date
March 11 2021
End Date
March 11 2027
Last Update
November 15 2024
Active Locations (7)
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1
Wiener Gesundheitsverbund-Klinik Penzing
Vienna, Austria, 1180
2
DRK Klinikum Berlin
Berlin, Germany, 14050
3
Wirbelsäulenzentrum Fulda Main, Kinzig
Gelnhausen, Germany, 63571
4
Medizinisches Versorgungszentrum Steinburg
Itzehoe, Germany, 25524