M50.1 M50.9
Conditions
Interventions
Group 1: Implantation of Cadisc-C
Group 2: Implantation of Rotaio
Sponsors
Zentrum für NeurochirurgieKlinik und Poliklinik für Allgemeine NeurochirugieUniversitätsklinikum Köln
Eligibility
Sex/Gender
All
Age
18 Years to 42 Years
Inclusion criteria
Inclusion criteria: - centered cervical herniated disc - Indication for monosegmental cervical ventral discectomy and implantation of a disc prosthesis as replacement of the removed disc - Written consent and age 18-42 years
Exclusion criteria
Exclusion criteria: • Clinical symptoms and radiological signs of cervical spine degeneration secured • Projects identified through planning software VertaplanTM necessary Interponathöhe of less than 5 mm. • Sensorimotor paraplegic syndrome • Cervical myelopathy • A previous open surgery on the cervical spine • acute stenosis occurred after trauma • Radiographic signs of instability ( listhesis ) to be operated in the segment • signs of instability ( listhesis ) in another segment of the cervical spine • General contraindication for elective spine intervention • Pathological fractures osteoporosis with pathological fracture • Active systemic infection • diseases of the rheumatic • bone metabolic diseases (eg Paget's disease ) • Skeletal metastases • infections in the cervical spine • Neurological seizure disorders or other severe neurological disease with risk of falls • Severe heart failure (NYHA III -IV) • bleeding disorders or Clopidogrel-/Marcumartherapie • Systemic corticosteroids for more than a month in the last 12 months prior to randomization • Simultaneous participation in other clinical trials over the past 30 days prior to randomization • Known allergy or intolerance to implants • Patient with possible dependence on sponsor or investigator • Inadequate knowledge of the German language • Accommodation in an institution for a court or administrative order • Lack of business ability • Pregnancy or lactation • Lack of written consent for study participation
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change in the radiologically evaluated height of the intervertebral space with an implanted interposition between baseline to (1-2 days postoperatively ) , 6 weeks , 6 months and 12 months follow-up Radiological instability between baseline to (1-2 days postoperatively ) , 6 weeks , 6 months and 12 months follow-up Change in the shoulder / arm pain (VAS ) (baseline to 6 weeks , 3, 6 , 12 and 24 months follow-up ) Change in the subscores for quality of life using the EQ-5D VAS (baseline to 6 weeks , 3, 6 , 12 and 24 months follow-up ) Change in the subscores for the dimensions mobility , independence, activity , pain, anxiety / depression in the EuroQol EQ-5D questionnaire (baseline to 6 weeks , 3, 6 , 12 and 24 months follow-up ) Pain evaluation using the COMI (baseline to 6 weeks , 3, 6 , 12 and 24 months follow -up ) ability to work Change in the postoperative neck pain (VAS ) between baseline and 6 weeks , 3, 6 , 12 and 24 months Perioperative mortality after 6 weeks, 3 , 6, 12 and 24 months Operation -specific data ( blood loss, operative time ) Medical treatment with painkiller Complications of treatment | — |
Primary
| Measure | Time frame |
|---|---|
| Cadisc-C shows in comparison to the intervertebral disc prosthesis Rotaio an improvement in the pain caused dayly life restrictions (NDI) between preoperatively and 12 months postoperatively evaluated by AUC. | — |
Countries
Germany
Contacts
Public ContactDaniel Rueß
Universitätsklinikum KölnZentrum für Neurochirurgie
Outcome results
None listed