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To evaluate the procedure and safety profile of the AGN1 Femoral LOEP Kit. This pilot study will be used to evaluate AGN1 Femoral LOEP treatment in a contralateral proximal femur during hip fracture repair.
The research will be conducted as a prospective single-center study within Hong Kong. The maximum number of subjects to be treated is twenty (20). This will be a non-randomized and non-blinded study.
Subjects having had a fragility hip fracture on one side will be treated with LOEP in the contralateral non-fractured proximal femur in the same operative session as the surgical repair of the fractured hip. A fragility fracture is defined as a fracture resulting from a fall from standing height.
All subjects will undergo hip fracture repair as recommended by the treating orthopedic surgeon. Repair may include nailing, plates, screws and hip prosthesis.
Subjects may continue to receive, or when appropriate, can be commenced on a treatment regime for osteoporosis. This decision will be made by the treating physician who will determine the best course of action for each patient. The outcome of this decision will have not affect the patient's eligibility for this trial.
Follow-up visits will be conducted at three (3) months, six (6) months, twelve (12) months, and twenty-four (24) months after the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN1 Treatment | Other | Subjects who have suffered a fragility hip fracture in one hip, sign the consent form and meet the inclusion and none of the exclusion of the study will receive the AGN1 Femoral Local Osteo-Enhancement Procedure (LOEP™) in the non-fractured hip. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN1 Femoral Local Osteo-Enhancement Procedure Kit | Device | A procedure that is intended to replace lost bone and increase the strength of the proximal femur in individuals with osteoporosis of the femoral neck. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment or Device Emergent Serious Adverse Events | Incidence of all serious adverse events (SAEs) occurring from the day of procedure through the twenty-four (24) month follow-up period determined to be definitely related to Femoral LOEP and/or the AGN1 device. | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Non-Treatment Emergent Fragility Fractures | Incidence of fragility fractures unrelated to the device or procedure occurring during the follow-up period. | 24 Months |
| Incidence of Treatment or Device Emergent Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Fang, MD | Queen Mary Hospital, Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital - Department of Orthopaedics and Traumatology | Hong Kong | Hong Kong |
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| Label | URL |
|---|---|
| Company website | View source |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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Incidence of all adverse events occurring from the day of procedure through the twenty-four (24) month follow-up determined to be definitely related to Femoral LOEP and/or the AGN1 device.
| 24 Months |
| Change in Bone Mineral Density between Baseline and 12 Months | Evaluation of bone mineral density (BMD) post-procedure at twelve (12) months. | 12 Months |
| Change in Bone Mineral Density between Baseline and 24 Months | Evaluation of bone mineral density (BMD) post-procedure at twenty-four (24) months. | 24 Months |
| D007869 |
| Leg Injuries |
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |