An observational study in Degenerative Disc Disease Lumbar and Spondylolisthesis, Grade 1, sponsored by BAAT Medical Products B.V.. Recruiting at 2 sites in Spain. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by BAAT Medical Products B.V. · Observational
This study is setup to be able to gather information on the safety and performance of the Fortilink-TC 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-TC 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-TC 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.
This study is setup to be able to gather information on the safety and performance of the Fortilink-TC 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-TC 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-TC 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.
227 studies on the registry are indexed under Spondylolisthesis; 43 are open to participants now.
This study's planned enrollment of 50 is below the median of 108 across 79 observational studies indexed under Spondylolisthesis.
Browse Spondylolisthesis studies →BAAT Medical Products B.V. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
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Patients matching the indications for the device, treated in the clinical selected for participation in the study
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Transforaminal lumbar interbody fusion surgery
Fortilink-TC Ti
Change in ODI score at 12 months follow-up
Change between baseline and 12 months follow-up
Time frame: Improvement in ODI score at 12 months over baseline
Change in VAS back and leg pain scores
Time frame: Baseline to 12 months post-surgery
Incidence of complications and adverse events
Time frame: Up to 12 months post-surgery
Incidence of imaging-confirmed complications
Imaging confirmed complications, such as subsidence, implant migration, or implant failure/breakage, identified during routine follow-up
Time frame: During follow-up through 12 months post-surgery
Radiographic fusion status
Fusion status based on imaging performed during routine follow-up
Time frame: During follow-up through 12 months post-surgery
Plan to share: Undecided
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