Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. 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 between September 2019 and January 2026. Subjects treated as part of an AgNovos prior protocoled study are excluded. Investigators are asked to reach out to all subjects that were previously treated with the AGN1 LOEP Kit in the proximal femur. Subject informed consent is obtained before a subject is enrolled into the study. Subjects treated but not enrolled are documented in a log with the reason why a subject did not participate. This log is kept on site. Enrolled subjects will be contacted per telephone to collect information about any fractures sustained post-AGN1 LOEP treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN1 LOEP | Device | Patients treated with AGN1 LOEP |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of fragility fractures of AGN1 LOEP treated hip | Through study completion, an average of 6 months. | |
| Incidence of all adverse events and serious adverse events occurring intraoperative and post-AGN1 LOEP determined to be at least possibly related to the procedure and/or device | Through study completion, an average of 6 months. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
-The subject's AGN1 LOEP treatment was previously performed as part of an AgNovos prior protocoled clinical study.
Not provided
Not provided
Not provided
Not provided
All subjects whose AGN1 LOEP treatment was performed outside of a prior AgNovos sponsored clinical study are considered for this study. The study anticipates enrolling up to 305 subjects. The final sample size may be smaller depending on willingness to participate or subject availability
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitaz | Sint-Niklaas | Belgium |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D006620 | Hip Fractures |
| D010013 | Osteogenesis Imperfecta |
| D007014 | Hypophosphatasia |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008664 | Metal Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |