PMCF Study Fortilink-TS Ti
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Zgoda na udział w badaniu
- •Dojrzałość szkieletowa (zakończony wzrost kostny)
- •Minimum 6 miesięcy leczenia bez operacji
- •Zmiany zwyrodnieniowe w dolnym odcinku kręgosłupa (jeden lub dwa kolejne segmenty) potwierdzone badaniami
- •Ból pleców pochodzenia tarczowego potwierdził badaniami obrazowymi
✗ Disqualifies
- •Aktywna infekcja w ciele lub w miejscu operacji
- •Alergia na materiały implantu
- •Osteoporoza zaawansowana
- •Nowotwory pierwotne lub przerzutowe w obrębie kręgosłupa
- •Otyłość morbidna lub inne choroby zwyrodnieniowe obciążające kości
- •Złamania, poważne deformacje lub niestabilność w miejscu zabiegu
- •Ciąża
- •Brak możliwości lub chęci udziału w badaniu i rehabilitacji
Simplified criteria — AI translation
Trial details
- Last updated (source)
- September 22, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (2)
Clinica Santa Elena
Madrid, Spain
Centro Médico Asturias
Oviedo, Spain
Trial contact
Tess Jimenez - van Dam, MSc
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/23/2026.
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