Hip Fractures Clinical Trial
Official title:
Clinical Investigation of a Local Osteo-Enhancement Procedure's (LOEP) Ability to Strengthen the Contralateral Femur of Women After a Fragility Fracture of the Hip in Hong Kong
Verified date | November 2022 |
Source | AgNovos Healthcare, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: 1. Subject is a postmenopausal female 2. Subject has a low-energy fragility hip fracture in one hip and will undergo surgical repair of the fractured hip. 3. Subject is = 65 years of age. 4. Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study. 5. Subject is capable of giving written informed consent to participate in the study. Exclusion Criteria: 1. Subject has a prior diagnosis of secondary osteoporosis. 2. Subject has history of any hip surgery or previous hip fracture in the non-fractured hip. 3. Subject has progressive increase in undiagnosed hip pain over the previous six (6) months that in the opinion of the Investigator may suggest other underlying bone or joint pathology (e.g. osteoarthritis, fracture, etc.). 4. Subject has serum calcium levels outside the normal lab range as per local guidelines and reference ranges. 5. Subject has moderate to severe renal insufficiency as per local guidelines and reference ranges. 6. Subject has insulin-dependent diabetes mellitus (IDDM). 7. Subject has Body Mass Index (BMI) > 30. 8. Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by the principal investigator*. 9. Subject exhibits excessive alcohol consumption as determined by the principal investigator*. 10. Subject has radiological evidence of gross bony or joint pathology of the non-fractured hip. 11. Subject treated with corticosteroids or systemic glucocorticoids for ten (10) days in the previous six (6) months. 12. Subject has history of oral or parenteral use of immune-suppressive drugs in the previous twelve months. 13. Subject has history of metabolic bone disease other than osteoporosis (eg. Paget's disease). 14. Subject has a history of auto-immune arthritic diseases including rheumatoid, psoriatic, or those associated with systemic lupus erythematosus, spondyloarthropathy, Reiter's Syndrome or Crohn's Disease. 15. Subject has a history of radiation therapy to the hip or pelvic region. 16. Subject has history of chemotherapy treatment for any condition within the previous five years. 17. Subject has history of any diagnosis and treatment of malignancies (excluding basal cell carcinoma) within the previous five years. 18. Subject has known allergies to implanted device. 19. Subject has severe comorbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate. 20. Subject is currently enrolled in another clinical study. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Queen Mary Hospital - Department of Orthopaedics and Traumatology | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
AgNovos Healthcare, LLC |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Incidence of Treatment or Device Emergent Adverse Events | 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 | |
Secondary | Change in Bone Mineral Density between Baseline and 12 Months | Evaluation of bone mineral density (BMD) post-procedure at twelve (12) months. | 12 Months | |
Secondary | 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 |
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