NCT03268356

STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: AgNovos Healthcare, LLC · Industry
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hip Fractures
• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-08-15
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2017-08-31
• Last updated: 2022-11-30

Locations

1 site across 1 country: Hong Kong