Discopathy Disc hernia with radiculopathy Stenosis of the foramen and spinal canal M50 M48
Conditions
Interventions
Group 1: Patients with indication of discopathy, disc hernia with radiculopathy and/ or stenosis of the foramen and spinal canal will be observed over 24 months. At follow-up times after 6 weeks, 6, 1
Sponsors
NGMedical GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must meet the following 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. The 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
Exclusion criteria: MOVE®-C should not be implanted in patients with the following conditions: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined endpoint defined as: • Improvement of the Neck Disability Index (NDI) and • Improvement of Visual Analogue Scales (VAS arm) and • Improvement of Visual Analogue Scales (VAS neck) The clinical results are compared to the 24 months visit (FU4, postoperative) before the operation (preoperatively). | — |
Secondary
| Measure | Time frame |
|---|---|
| Endpoints are defined as: • Core Outcome Measure Index (COMI neck) • Short Form 36 Health Survey Questionnaire (SF-36) • EuroQol (EQ-5D-5L) • Japanese Orthopedic Association Score (JOA) • radiographic outcome assessment by the analyse of the Range of Motion (ROM) • Monitoring of product related occurrence of adverse events (AE-Monitoring) The clinical and radiological results are compared to the 24 months visit (FU4, postoperative) before the operation (preoperatively). | — |
Countries
Austria, Germany
Contacts
Public ContactSaskia Mathieu
NGMedical GmbH
Outcome results
None listed