MOVE®-C: Momo- or bisegmental implantation of MOVE®-C cervical prothesis.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion 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. 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:
* 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).
Primary outcome measure(s)
Improvement from baseline on Neck Disability Index (NDI) — Baseline and month 24 Primary outcome measure 1 and 2 are combined endpoints. Improvement of the NDI of more than 15 points for a change (pre-postoperative) of up to 30 points with a standard deviation of 25 points.
Improvement from baseline on Visual Analogue Scales (VAS arm/neck) — Baseline and month 24 Primary outcome measure 1 and 2 are combined endpoints. Improvement of arm and neck pain scale (VAS arm/neck) of more than 2 points at a change (pre-postoperative) of 2.7 points with a standard deviation of 2.5 points.
Trial sites (7)
Facility
City
Region
Status
Wiener Gesundheitsverbund-Klinik Penzing
Vienna
Austria
Recruiting
DRK Klinikum Berlin
Berlin
Germany
Recruiting
Wirbelsäulenzentrum Fulda Main, Kinzig
Gelnhausen
Germany
Recruiting
Medizinisches Versorgungszentrum Steinburg
Itzehoe
Germany
Recruiting
Katholisches Klinikum Koblenz - Montabaur
Koblenz
Germany
Recruiting
Neurochirurgie am Gasteig
München
Germany
Recruiting
Rhein-Maas Klinikum Würselen
Würselen
Germany
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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