Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Tre… (NCT06261242) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment
Taiwan12 participantsStarted 2023-06-16
Plain-language summary
This study is to evaluate the safety and effectiveness of the Tripod-Fix with Tecres Mendec® Spine HV System to treat subjects with osteoporotic vertebral compression fractures.
Who can participate
Age range50 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.
✓. Male or female with at least 50 years of age.
✓. 1 painful VCF which meet all of the following criteria:
✓. Fracture due to diagnosed or presumed underlying osteoporosis (T-score \< -2.5 points).
✓. VCF between T7 and L4.
✓. Fracture age \< 3 months.
✓. VCF shows loss of height in the anterior, mid or posterior third of the vertebral body from an estimated pre-fracture configuration of at least 15% but not more than 40% based on X-ray, CT or MRI at baseline.
Exclusion criteria
✕. Target VCF due to high-energy trauma or underlying/suspected tumor.
✕. Target VCF is diagnosed as an osteonecrosis.
✕. Segmental kyphosis of target vertebral compression \> 30°.
✕. Any prior surgical treatment for a VCF or other surgical procedure on the target vertebral body or adjacent level.
✕. The patient has uncontrolled systemic diabetes (A1c \> 10) and /or uncontrolled hypertension (patient requiring 3 or more anti-hypertensive drugs).