Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT05035693
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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05035693
Study Brief:
Protocol Section:
NCT05035693