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PMCF Study Fortilink-TS Ti
Sponsor: BAAT Medical Products B.V.
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.
Official title: Post-market Clinical Study of the Fortilink-TS Ti
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2026-01-01
Completion Date
2027-12-31
Last Updated
2026-09-22
Healthy Volunteers
No
Interventions
Posterior lumbar interbody fusion surgery
Fortilink-TS Ti
Locations (2)
Clinica Santa Elena
Madrid, Madrid, Spain
Centro Médico Asturias
Oviedo, Principality of Asturias, Spain