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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00020523
Enrollment
60
Registered
2020-02-03
Start date
2020-02-08
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Group 1: Patients are before and after the surgery with the MOBIS II ST cage-implant examined and their status is documented. During the examinations, the visual analog scale (VAS), the Oswestry disab

Sponsors

SIGNUS Medizintechnik GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Bony fusion's rate one year after the surgery in the implanted segement(s)

Secondary

MeasureTime frame
- Changes in pain, function and quality of life of the patient bevor and after the surgery (VAS, ODI, SF-12) - Post-operative patient satisfaction (PSI) - Post-operative clinical therapy success - Safety of the implant

Countries

Germany

Contacts

Public ContactMelissa Rohde

SRH Wald-Klinikum Gera - Zentrum für klinische Studien

melissa.rohde@srh.de00493658287758

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026