Post-Market Clinical Follow-up (PMCF) Study with the MOBIS II ST cage-implant for transforaminal lumbar fusion (TLIF)

• Conditions: Diseases of the lumbar spine (L1-S1) like degenerative disc diseases, mechanical instability and osteochondrosis.; M42.16; M43.16; M43.17; M47.26; M48.06; M51.2; M51.3; M53.26; M47.17

• Registration Number: DRKS00020523
• Lead Sponsor: SIGNUS Medizintechnik GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Patients who are implanted routinely and in accordance with the certification of MOBIS II ST

Exclusion Criteria

- Pregnant and breastfeeding women
- Patients incapable of giving consent
- Younger than 18 years old
- Patients without informed consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bony fusion's rate one year after the surgery in the implanted segement(s)

Secondary Outcome Measures

Name	Time	Method
- Changes in pain, function and quality of life of the patient bevor and after the surgery (VAS, ODI, SF-12)<br>- Post-operative patient satisfaction (PSI)<br>- Post-operative clinical therapy success<br>- Safety of the implant