Trochanteric Femur Fracture Operated With Dynamic Hip Screw System (DHS) Augmented With a Biphasic Apatite Sulphate Combined With Systemic or Local Bisphosphonate

NAActive, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 1, 2021

Primary Completion Date

June 30, 2024

Study Completion Date

December 31, 2024

Conditions
Trochanteric Fracture of Femur
Interventions
PROCEDURE

OSTEOSYNTHESIS

Routine procedure for anesthesia and infection prophylaxis according to the clinics routines will be followed. The patient is supine with the fractured leg positioned in traction table. The biplanar x-ray device is moved and adjusted for proper simultaneous AP and lateral view. Hip region is washed and dressed in sterile draping's. Using standard proximal femur osteosynthesis technique 2.0 mm diameter Kirschner wire is placed in the middle zone of the femoral neck in AP and lateral view. The canal is opened using 6 mm drill bit and measured length of dynamic hip screw is placed in the femoral head and neck.

DRUG

Zoledronic Acid

Zoledronic acid (ZA), is a bisphosphonate, and has been shown to reduce the risk of hip fracture by 41% in post-menopausal women. For systemic injection, 4 mg (as per clinical protocol) will be injected intravenously 1-2 weeks after surgery. For local delivery, 1 or 2 mg Zoledronic Acid will be added to 5 or 10 mg CERAMENT BVF during mixing and the mixture will be injected.

DEVICE

CERAMENT BONE VOID FILLER (BVF)

"CERAMENT™\

Trial Locations (1)

Unknown

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas

All Listed Sponsors
collaborator

Lund University Hospital

OTHER

lead

Lithuanian University of Health Sciences

OTHER

NCT04498715 - Trochanteric Femur Fracture Operated With Dynamic Hip Screw System (DHS) Augmented With a Biphasic Apatite Sulphate Combined With Systemic or Local Bisphosphonate | Biotech Hunter | Biotech Hunter