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RECRUITING
NCT07834736

PMCF Study Fortilink-TS Ti

Sponsor: BAAT Medical Products B.V.

View on ClinicalTrials.gov

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

PROCEDURE

Posterior lumbar interbody fusion surgery

Fortilink-TS Ti

Locations (2)

Clinica Santa Elena

Madrid, Madrid, Spain

Centro Médico Asturias

Oviedo, Principality of Asturias, Spain