Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral … (NCT06270173) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures
Germany53 participantsStarted 2024-02-16
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form prior to any study procedures
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Skeletally mature males and females
✓. 1 painful VCF which meets all of the following criteria:
✓. Fracture due to diagnosed or presumed underlying osteoporosis (T-score \< -2.5 points)
✓. VCF between T6 and L5
✓. VCF shows loss of height in the anterior, mid or posterior third of the vertebral body from an estimated pre-fracture configuration, but no more than 50% based on X-ray, CT or MRI at baseline.
✓. The Index fracture is acute or persistent (not healed), as demonstrated by MRI (or bone scan if the patient is contraindicated for MRI).
Exclusion criteria
✕. Patient presenting a loss of vertebral height \>50% compared to estimated pre-fracture height
✕. Sclerotic fracture
✕. Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement
✕. Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the moment of surgery or at least 8 days prior to inclusion