PMCF Study Fortilink-TS Ti
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBAAT Medical Products B.V.
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to give voluntary informed consent
Skeletally mature patients
At least 6 months of non-operative treatment
Degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels between L2 and S1, with DDD being defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, and/or up to grade 1 spondylolisthesis of the lumbar spine at one or two contiguous levels between L2 and S1
Disqualifiers
Active systematic infection or an active infection at the operative site
A demonstrated allergy or sensitivity to any of the implanted materials
Severe osteoporosis (confirmed by imaging in the patient's medical history or during screening)
Primary or metastatic tumours affecting the spine (confirmed by imaging in the patient's medical history or during screening)
Trial population
Patients matching the indications for the device, treated in the selected clinic
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Posterior lumbar interbody fusion surgery
Procedure/SurgeryFortilink-TS Ti
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Fortilink-TS - treated patients1 intervention
Trial outcomes
Primary outcomes
1
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 baselineSecondary outcomes
1
Change in VAS back and leg pain scores
Time frame
Baseline to 12 months post-surgery2
Incidence in complications and adverse events
Time frame
Up to 12 months post-surgery3
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-surgery4
Radiographic fusion status
Fusion status based on imaging performed during routine follow-up
Time frame
During follow-up through 12 months post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov