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Prospective multicenter evaluation of a novel vertebral body replacement implant POSEIDON ST with 3D printed endplates

Prospective multicenter evaluation of a novel vertebral body replacement implant POSEIDON ST with 3D printed endplates - POSEIDON

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00032277
Enrollment
120
Registered
2023-07-17
Start date
2023-08-15
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

S32.0 S22.0 C79.5 M46.2

Interventions

Group 1: Patients treated with a POSEIDON ST vertebral body replacement implant

Sponsors

SIGNUS Medizintechnik GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria are the indication for surgical treatment with POSEIDON ST and the availability of a consent form. Only patients who have given their written consent to participate in accordance with data protection regulations will be included in the study.

Exclusion criteria

Exclusion criteria: - Age <18 years - Participants unable to give consent, e.g. due to cognitive impairments - Pregnant women who are breastfeeding - Patients for whom consent is not available

Design outcomes

Primary

MeasureTime frame
Follow-up times: 3 months, 1 year, 2 years Fusion rate (radiological, functional images) Migration and sintering (radiological) Corrective gain loss (radiological) Safety and implant associated complications (general and surgical complications)

Secondary

MeasureTime frame
Follow-up times: 3 months, 1 year, 2 years Functional outcome (ODI, EQ-5D) Postoperative pain relief (VAS, analgesic consumption) Neurological status (Frankel scale) Patient satisfaction (scale) Quality of life (ODI, EQ-5D)

Countries

Germany

Contacts

Public ContactChristoph – E. Heyde

Universitätsklinikum Leipzig AöR

studien-oup@medizin.uni-leipzig.de+493419723000

Outcome results

None listed

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