STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture
NCT03268356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2022-11-30
Summary
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.
Conditions
- Hip Fractures
- Osteoporosis, Postmenopausal
Interventions
- DEVICE
-
AGN1 Femoral Local Osteo-Enhancement Procedure Kit
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.
Sponsors & Collaborators
-
AgNovos Healthcare, LLC
lead INDUSTRY
Principal Investigators
-
Christian Fang, MD · Queen Mary Hospital, Hong Kong
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-15
- Primary Completion
- 2020-12-31
- Completion
- 2020-12-31
Countries
- Hong Kong
Study Locations
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