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The study is designed as a retrospective, single-center study for subjects previously treated with the AGN1 LOEP Kit. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated outside of any other clinical study protocols between September 2019 and November 2022. A prospective questionnaire will be included to evaluate self-reported subject experiences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with AGN1 LOEP |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject satisfaction | Satisfaction level of subjects as measured by a Visual Analog Scale. The scale ranges from the lowest possible satisfaction to the highest possible satisfaction. | Through study completion, an average of 1.1 years |
| Subject Safety | Incidence of all adverse events and serious adverse events occurring intraoperative determined to be at least possibly related to the procedure and/or device. | During the procedure |
| Subject Safety | Incidence of all adverse events and serious adverse events occurring post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device. | Through study completion, an average of 1.1 years |
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Inclusion Criteria:
Exclusion Criteria:
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Osteopenic and osteoporotic subjects receiving AGN1 LOEP treatment of the proximal femur.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitaz | Sint-Niklaas | 9100 | Belgium |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |