The objective of this Post-Market Clinical Follow-Up Study is to evaluate the safety and performance of the Tripod-Fix in the treatment of vertebral compression fractures (VCF) resulting from osteoporosis.
This study is a prospective, multicenter, open-label, single-arm, PMCF study. The sample size for this study will be 50 patients. Eligible patients will be treated with Tripod-Fix on Day 0 and will be followed for a total of 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
The Tripod-Fix is a permanent implant used for vertebral augmentation in patients with osteoporotic vertebral compression fractures.
Klinikum Friedrichshafen
Friedrichshafen, Baden-Wurttemberg, Germany
University Hospital Mannheim
Mannheim, Baden-Wurttemberg, Germany
Johann Wolfgang Goethe University Frankfurt/Main
Frankfurt am Main, Hesse, Germany
Krankenaus Mechernich
Mechernich, North Rhine-Westphalia, Germany
Proportion of participants with study success
Study success is defined as follows: 1. The reduction of Visual Analogue Scale (VAS) score \> 20 mm at the 12 month follow up visit compared to baseline as measured by the 100-mm VAS measurement, AND 2. Maintenance or improvement in function at the 12 month follow up visit compared to baseline as measured by the 100-point Oswestry Disability Index (ODI) AND, 3. Absence of device-related serious adverse events.
Time frame: 12 months post-procedure
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