Discopathy, Herniated Cervical Disc, Radiculopathy, Stenoses, Spinal
Conditions
Keywords
Herniated Disc, Cervical Spine, Discopathy, Radiculopathy
Brief summary
Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG. Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.
Detailed description
This clinical investigation is conducted to gain post market results on the Cervical Disc Prosthesis MOVE®-C and to demonstrate the safety and performance. Besides, it is aimed to gain knowledge concerning the development of patients' quality of life (QoL) after the implantation of the Cervical Disc Prosthesis MOVE®-C and to collect data for the analysis of the range of motion (ROM), which is an essential parameter for motion-preserving implants.
Interventions
DEVICEMOVE®-C
Momo- or bisegmental implantation of MOVE®-C cervical prothesis.
Sponsors
NGMedical GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement from baseline on Neck Disability Index (NDI) | Baseline and month 24 | Primary outcome measure 1 and 2 are combined endpoints. Improvement of the NDI of more than 15 points for a change (pre-postoperative) of up to 30 points with a standard deviation of 25 points. |
| Improvement from baseline on Visual Analogue Scales (VAS arm/neck) | Baseline and month 24 | Primary outcome measure 1 and 2 are combined endpoints. Improvement of arm and neck pain scale (VAS arm/neck) of more than 2 points at a change (pre-postoperative) of 2.7 points with a standard deviation of 2.5 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in EuroQoL (EQ-5D-5L) | Baseline and moths 24 | The clinical results of (EQ-5D-5L) will be compared to the 24 months visit before the operation. |
| Change from baseline in Japanese Orthopedic Association Score (JOA) | Baseline and moths 24 | The clinical results of (JOA) will be compared to the 24 months visit before the operation. |
| Change from baseline in Core Outcome Measure Index (COMI neck) | Baseline and months 24 | The clinical results of COMI neck will be compared to the 24 months visit before the operation. |
| Monitoring of product related occurence of adverse events (AE-Monitoring) | Baseline and moths 24 | The radiological results of the AE-Monitoring are compared to the 24 months visit before the operation. |
| Analyse of the Range of Motion (ROM) | Baseline and moths 24 | The radiological results of the ROM are compared to the 24 months visit before the operation. |
| Change from baseline in Short Form 36 Health Survey Questionnaire (SF-36) | Baseline and moths 24 | The clinical results of SF-36 will be compared to the 24 months visit before the operation. |
Countries
Austria, Germany
Contacts
Primary ContactSaskia Mathieu, M.Sc.
Backup ContactNino Weiland, B.Sc.
Outcome results
None listed