Observational study on the MOVE®-C cervical disc prosthesis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international, prospective, multicentre, non-randomised, observational study aims to confirm the safety and performance of the MOVE®-C cervical disc prosthesis. It will collect post-market data to assess the quality of life improvements and the range of motion in patients after implantation. The study will involve patients diagnosed with discopathy or herniated cervical discs who have not responded to conservative treatment. Data will be gathered to evaluate the effectiveness of this motion-preserving implant.

Why it matters

Who can join: the full rules

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).

Where it's running

• 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

Study contacts

• Principal investigator: Olaf Süss, PD Dr. med. — DRK Kliniken Berlin
• Study coordinator: Saskia Mathieu, M.Sc.
• Email: smathieu@ngmedical.de
• Phone: +49687399997118

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.