Observational study on the MOVE®-C cervical disc prosthesis

"PMCF MOVE®-C" International, Prospective, Multicentre, Non-randomised Post-market Clinical Follow-up Study Clinical and Radiological Outcome After Mono- and Bisegmental Cervical Intervertebral Disc Prosthetics

This study is testing how well the MOVE®-C cervical disc prosthesis works and if it can improve the quality of life and movement for patients with neck disc problems who haven't found relief from other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NGMedical GmbH (Industry-sponsored)
• Locations: 7 sites (Vienna and 6 other locations)
• Trial ID: NCT05035693 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with diagnosed discopathy or herniated cervical discs accompanied by radiculopathy or stenosis.

Not a fit: Patients with known contraindications to cervical intervertebral disc prostheses or those who have had recent surgical treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance treatment options for patients suffering from cervical disc issues by providing a safer and more effective prosthesis.

How similar studies have performed: Other studies on cervical disc prostheses have shown promising results, indicating that this approach is supported by prior successful outcomes.

Eligibility criteria

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 this trial is running

Vienna and 6 other locations

• 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)

Study contacts

• Principal investigator: Olaf Süss, PD Dr. med. — DRK Kliniken Berlin
• Study coordinator: Saskia Mathieu, M.Sc.

Conditions Discopathy; Herniated Cervical Disc; Stenoses, Spinal; Radiculopathy; Herniated Disc; Cervical Spine