PMCF Study Fortilink-TS Ti
Condition(s) studied
Investigational drug(s) / intervention(s)
Posterior lumbar interbody fusion surgery: Fortilink-TS Ti
Study summary
This study is setup to be able to gather information on the safety and performance of the Fortilink-TS Ti cage of Paradigm Spine GmbH, up to one-year after the surgery. The device is intended to be used in intervertebral fusion surgery. Around 50 participants will participate in this study in 2 hospitals.
The Fortilink-TS Ti cage is meant to be placed in the lower back, to treat degenerative disc disease with up to grade I spondylolisthesis. The study will involve data gathering based on routine care. The study will only entail collection of data (medical history prior to the surgery, data from the surgery and data in the follow up after one year). Fortilink-TS Ti cages are not new, but have been on the market since 2020. The clinical study is performed to actively gather data on the use of this product in the intended group of patients, to monitor its safety and performance. The treatment and follow-up provided in this study does not differ from the standard of care; meaning that participants in the study will receive the same treatment and follow the same follow-up visits and assessments as patients undergoing the same procedure outside of the study.
Eligibility
Primary outcome measure(s)
- Change in ODI Score at 12 months follow-up — Improvement in ODI score at 12 months over baseline
Change between baseline and 12 months follow-up
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinica Santa Elena | Madrid | Madrid | Recruiting |
| Centro Médico Asturias | Oviedo | Principality of Asturias | Recruiting |
More BAAT Medical Products B.V. trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07834736 on ClinicalTrials.gov ↗ ← All trials in Spain