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| Name | Class |
|---|---|
| Avania | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Tripod-Fix will be used to treat osteoporotic vertebral compression fractures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix) | Device | The Tripod-Fix is a permanent implant used for vertebral augmentation in patients with osteoporotic vertebral compression fractures. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with study success | Study success is defined as follows:
| 12 months post-procedure |
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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:
Investigator believes target vertebral body is suitable for Tripod-Fix procedure (e.g., appropriate pedicle diameter) assessed on radiography preoperative.
Exclusion Criteria:
Tripod-Fix is not indicated for any other application other than that for which it is designed. contraindications for Tripod-Fix include, but are not limited to: .
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| Name | Affiliation | Role |
|---|---|---|
| Te-Yang Tsai | Wiltrom Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Friedrichshafen | Friedrichshafen | Baden-Wurttemberg | 88048 | Germany | ||
| University Hospital Mannheim |
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| Mannheim |
| Baden-Wurttemberg |
| 68167 |
| Germany |
| Johann Wolfgang Goethe University Frankfurt/Main | Frankfurt am Main | Hesse | 60596 | Germany |
| Krankenaus Mechernich | Mechernich | North Rhine-Westphalia | 53894 | Germany |