Multicenter observational study to assess surgical outcomes after implantation of a JASPIS ST cage (ACDF)

• Conditions: M50.1; M50.2; Cervical disc disorder with radiculopathy; Other cervical disc displacement

• Registration Number: DRKS00025019
• Lead Sponsor: SIGNUS Medizintechnik GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Medical indication for surgical treatment of the cervical spine using JASPIS ST, Presence of a declaration of consent, Patients who are at least 18 years old

Exclusion Criteria

Age < 18 years, Participants unable to give consent, e.g. due to cognitive impairment, Pregnant and breastfeeding women, Patients for whom consent is not available.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional result<br>Postoperative pain relief<br>Patient satisfaction<br>Quality of life<br><br>Survey using: Odom's criterion, mJOA, NDI, EQ-5D-5L, PI, analgesic use<br><br>Survey at all time points of preoperative and postoperative follow-up (except Odom's criterion and PI - postoperative only).<br>

Secondary Outcome Measures

Name	Time	Method
Fusion rate (by imaging studies)<br>Sintering (by imaging studies)<br>Safety and implant-associated complications by safety CRF.