Multicentre observational study on the application of ROTAIO®-disc prosthesis

• Conditions: M50.1; M50.0; Cervical disc disorder with radiculopathy; Cervical disc disorder with myelopathy

• Registration Number: DRKS00007176
• Lead Sponsor: SIGNUS Medizintechnik GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-06
• Study Completion: 2021-06-14
• Results First Posted: 2022-08-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Intractable mono- or bisegmental radiculopathy due to a degenerative cervical disc disease or intractable myelopathy

Exclusion Criteria

Kyphosis in the index segment, instability in the index segment, severe osteochondrosis in the index segment, marked degenerative changes in the facet joints, previous surgery in the cervical spine

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite Success rate after 24 months:<br>1. Improvement of the NDI for more than 15%<br>2. Preservation/Improvement of the neurological Status<br>3. No re-operation, revision or removal of the implant<br>4. No complications associated with the implant<br><br>

Secondary Outcome Measures

Name	Time	Method
Determining the quality of life, mobility and freedom from pain by SF-36, NDI, WL-26 and VAS at 12 and 24 months<br>Index of patient satisfaction, analgesic consumption<br>Radiographic mobility after 12 and 24 months