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

NCT04498715 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-02-01

No results posted yet for this study

Summary

The purpose of this study is to study the process of bone regeneration around a metal device in the femoral neck canal using a synthetic bone substitute Cerament bone void filler (BVF) and bisphosphonate (Zometa) locally or systemically that affects bone metabolism. Furthermore, fracture healing and implant migration will be investigated.

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™\|BONE VOID FILLER is a synthetic, injectable, osteoconductive bone void filler. CERAMENT™I is biphasic, consisting of 60% calcium sulfate and 40% hydroxyapatite mixed with the radio-opacity enhancing component CERAMENT™\|C-TRU (iohexol 300 mg iodine/ml), which allows bone in-growth after curing. The high injectability of CERAMENT™ allows transcortical administration and ensures good intraosseous spread. In this trial, CERAMENT BVF paste will be injected by a sterilized metal needle (2-3 mm diameter and 15 cm length) through the hollow dynamic hip screw.

Sponsors & Collaborators

  • Lund University Hospital

    collaborator OTHER

  • Lithuanian University of Health Sciences

    lead OTHER

Principal Investigators

  • Sarunas Tarasevicius, MD,PhD · Lithuanian University of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04498715 on ClinicalTrials.gov