NCT07834749|Recruiting
PMCF Study Fortilink-SC
Post-market Clinical Study of the Fortilink-SC Ti
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Post-market Clinical Study of the Fortilink-SC Ti
Sponsor study identifier
observational
50
1 country
2
Study Start
January 1, 2026
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 8, 2025
Actual (reported)January 1, 2026
Actual (reported)September 22, 2026
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in NDI score at 12 months follow-up
Change between baseline and 12 months follow-up
Improvement in NDI score at 12 months over baseline
Change in VAS neck and arm pain scores
Baseline to 12 months post-surgery
Incidence of complications and adverse events
Up to 12 months post-surgery
Incidence of imaging-confirmed complications
During follow-up through 12 months post-surgery
Radiographic fusion status
During follow-up through 12 months post-surgery
Fortilink-SC
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients matching the indications for the device, treated in the clinical selected for participation in the study
Hospital Vithas de la Milagrosa
Madrid, Madrid, 28010, Spain
Hospital Universitario Vithas Madrid Aravaca
Moncloa-Aravaca, Madrid, 28023, Spain
First Submitted
July 8, 2025
First Posted
September 22, 2026
Study Start
January 1, 2026
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 22, 2026
Record last verified: 2026-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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