Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT03268356
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2017-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture
Sponsor:
AgNovos Healthcare, LLC
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: