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PMCF Study Fortilink-SC

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This study is setup to be able to gather information on the safety and performance of the Fortilink-SC 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-SC Ti cage is meant to be placed in the neck, to treat degenerative disc disease and/or stenosis. 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-SC 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.
Trial Details
NCT Number NCT07834749
Lead Sponsor BAAT Medical Products B.V.
Collaborators: Paradigm Spine, Archer Research
Conditions
(from sponsor)		 Degenerative Disc Disease in Cervical Spine, Stenosis Cervical Spine
Related terms Intervertebral Disc Degeneration
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov