FARE Augmentation of Proximal Femoral Fractures With CaS/HA and Systemic ZA

Phase 4

Recruiting

Conditions: Trochanteric Fracture of Femur
Osteoporotic Fracture of Femur
Hip Fractures
Bone Density, Low

Interventions: Procedure: OSTEOSYNTHESIS
Drug: Zoledronic acid
Device: CERAMENT BONE VOID FILLER (BVF)

Brief Summary: The goal of this clinical trial is to investigate the new bone formation around a metal device in the femoral head in patients with osteoporotic hip fractures undergoing surgical treatment with nails. These surgeries have a high risk of fixation failure in patients with osteoporosis due to low bone quality. The main question we aim to answer are whether prom...

Detailed Description: A total of 20 eligible patients with osteoporotic per trochanteric fractures, that are treated with proximal femoral nail (PFN), will be included in the study after informed and approved consent and will be randomized into two groups. Randomization will be performed by the principal investigator, by sealed envelopes, after determining if the patient fulfills...

Recruitment & Eligibility

Inclusion Criteria

Being between 65-90 years of age at the time of fracture
Acute, unilateral proximal hip fracture (AO Foundation/Orthopaedic Trauma Association [AO/OTA]: A1 and A2) caused by low energy trauma
Physical condition eligible for surgery with proximal femoral nail
Having low mortality and high fracture risk according to Fracture and Mortality Risk Evaluation Index (FAME) classification
Patient with communicative ability to understand the procedure and participate in the study and the follow-up program, consented to be included in the study and signed the consent form

Exclusion Criteria

Previous hip or pelvis fracture on the same side
Concurrent corticosteroid treatment
Concurrent medical osteoporosis treatment
Irreversible coagulopathy or bleeding disorder.

o Note regarding reversible coagulopathies: Patients on coumadin or other anticoagulants may participate. Investigators will follow routine practices for perioperative discontinuation and re-initiation of anti-coagulants.
Concurrent dialysis or elevated creatinine
Presence of hypo- or hyper calcaemia
History or active treatment due to malignancy involving the pelvis/hip area, including ongoing or completed radiotherapy
Fractures involving acetabulum
Active systemic infection or local skin infection at the incision site
Known hyperthyroidism or thyroid adenoma,
History of serious reaction to iodine-based radio contrast agents
Patient without communicative ability to understand the procedure and participate in the study and the follow-up program, did not consent to be included in the study and/or did not sign the consent form

Arm && Interventions

Group	Intervention	Description
OSTEOSYNTHESIS + SYSTEMIC ZOLEDRONIC ACID	OSTEOSYNTHESIS	After osteosynthesis, systemic Zoledronic acid 5mg will be given intravenously at day 5 after surgery, during hospitalization.
OSTEOSYNTHESIS + LOCAL CERAMENT BONE VOID FILLER (BVF) + SYSTEMIC ZOLEDRONIC ACID	OSTEOSYNTHESIS	During osteosynthesis, cerament BVF will be used for the augmentation of the helical blade. Then, systemic Zoledronic acid 5mg will be given intravenously at day 5 after surgery, during hospitalization.
OSTEOSYNTHESIS + LOCAL CERAMENT BONE VOID FILLER (BVF) + SYSTEMIC ZOLEDRONIC ACID	CERAMENT BONE VOID FILLER (BVF)	During osteosynthesis, cerament BVF will be used for the augmentation of the helical blade. Then, systemic Zoledronic acid 5mg will be given intravenously at day 5 after surgery, during hospitalization.
OSTEOSYNTHESIS + SYSTEMIC ZOLEDRONIC ACID	Zoledronic acid	After osteosynthesis, systemic Zoledronic acid 5mg will be given intravenously at day 5 after surgery, during hospitalization.
OSTEOSYNTHESIS + LOCAL CERAMENT BONE VOID FILLER (BVF) + SYSTEMIC ZOLEDRONIC ACID	Zoledronic acid	During osteosynthesis, cerament BVF will be used for the augmentation of the helical blade. Then, systemic Zoledronic acid 5mg will be given intravenously at day 5 after surgery, during hospitalization.

Primary Outcome Measures

Name	Time	Method
Bone remodeling around the helical blade of proximal femoral nail	1-week and 6 months after the surgery	Bone remodeling around the helical blade will be evaluated by computerized tomography (CT) scan of the pelvis using a program for alleviating metal artefacts. A 10 % increase in bone density / bone volume in the femoral head adjacent to the helical blade is expected to be significant and clinically relevant.
Change of bone density around the helical blade of proximal femoral nail	1-week and 6 months after the surgery	Change of bone density measured by Dual-energy X-ray absorptiometry (DEXA) scan of bilateral proximal femurs will be evaluated. A 10 % increase in bone density / bone volume in the femoral head adjacent to the helical blade is expected to be significant and clinically relevant.

Secondary Outcome Measures

Name	Time	Method
Screw position and migration by X-ray	1-week and 6 months after the surgery	X-ray evaluation will quantify helical blade migration on anteroposterior (AP) radiographs by two investigators independently, accounting for femoral rotation and flexion.
Any mechanical complications	6 months after the surgery	Any mechanical complications related to the implant will be recorded.
Harris Hip Score	1-week and 6 months after the surgery	The Harris Hip Score (HHS) has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points). The higher the HHS, the less dysfunction. A total score of \<70 is considered a poor result; 70-80 is considered fair, 80-90 is g...
Evaluation of fracture union	6 months after the surgery	Radiographic evaluation will be performed by two investigators independently to decide whether fracture fixation resulted with union or non-union.

Locations (1): Aksaray University Training and Research Hospital
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Aksaray, Turkey