COMPARISON OF SOFTWARE-ASSISTED IMPLANTATION OF CADISC-C WITH THE DISC PROSTHESIS ROTAIO IN the THERAPY OF CERVICAL DISC DISEASE IN TERMS OFPOSTOPERATIVE CHANGES IN NECK DISABILITY INDEX (NDI)A PROSPECTIVE, CONTROLLED AND RANDOMIZED STUDY

Not Applicable

• Conditions: M50.9; M50.1; Cervical disc disorder with radiculopathy; Cervical disc disorder, unspecified

• Registration Number: DRKS00005960
• Lead Sponsor: Zentrum für NeurochirurgieKlinik und Poliklinik für Allgemeine NeurochirugieUniversitätsklinikum Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 52

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

• 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.