Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C

Launched by NGMEDICAL GMBH · Aug 31, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a new cervical disc prosthesis called MOVE®-C, which is designed to help patients with neck problems like disc herniation, spinal stenosis, or nerve pain. The study is open to adults aged 18 and older who have been experiencing neck or upper arm pain and have not found relief from other treatments in the past six weeks. To participate, individuals must agree to take part in the study and provide written consent.

If you join this trial, you will be monitored to see how well the MOVE®-C prosthesis works for you over time. It’s important to know that there are certain health conditions that would prevent someone from participating, such as severe osteoporosis, active infections, or certain spinal deformities. The study aims to gather more information to help doctors understand how this device can improve the quality of life for patients with cervical spine issues.

Gender

ALL

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).