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

NCT04498715 | Unknown DMC

• 2 other identifiers: 20200723Lithuanian
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dynamic hip screw (DHS); Biphasic apatite sulphate ceramic; bisphosphonate-zoledronic acid

Outcome Measures

Primary Outcomes (1)

• Change of bone density and remodeling around the head of dynamic screw

  Bone density and remodelling around a dynamic hip screw will be investigated by CT scan using a program for alleviating metal artefacts. A 20% increase in bone density is expected to be significant and clinically relevant.

  1.5, 3, 6 months

Secondary Outcomes (2)

• Change of Harris Hip Score (HHS) in different group patients

  1.5, 3 and 6 months

• Change of the Screw migration by X-ray

  1.5, 3 and 6 months

Study Arms (2)

OSTEOSYNTHESIS+SYSTEMIC ZOLEDRONIC ACID

ACTIVE COMPARATOR

After osteosynthesis, systemic Zoledronic acid 4mg (or any other bisphosphonate) will be given intravenously between day 7-14 post operation.

Procedure: OSTEOSYNTHESIS; Drug: Zoledronic Acid

OSTEOSYNTHESIS+LOCAL CERAMENT BONE VOID FILLER (BVF)+SYSTEMIC ZOLEDRONIC ACID

EXPERIMENTAL

During osteosynthesis, cerament BVF will be used for the augmentation of the screw. Then systemic Zoledronic acid 4mg (or any other bisphosphonate) will be given intravenously between day 7-14 post operation.

Procedure: OSTEOSYNTHESIS; Drug: Zoledronic Acid; Device: CERAMENT BONE VOID FILLER (BVF)

Interventions

OSTEOSYNTHESIS PROCEDURE

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.

OSTEOSYNTHESIS+LOCAL CERAMENT BONE VOID FILLER (BVF)+SYSTEMIC ZOLEDRONIC ACID; OSTEOSYNTHESIS+SYSTEMIC ZOLEDRONIC ACID

Zoledronic Acid DRUG

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.

Also known as: Zometa

OSTEOSYNTHESIS+LOCAL CERAMENT BONE VOID FILLER (BVF)+SYSTEMIC ZOLEDRONIC ACID; OSTEOSYNTHESIS+SYSTEMIC ZOLEDRONIC ACID

CERAMENT BONE VOID FILLER (BVF) DEVICE

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.

OSTEOSYNTHESIS+LOCAL CERAMENT BONE VOID FILLER (BVF)+SYSTEMIC ZOLEDRONIC ACID

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients 65-90 years of age;
• Fame classification with low mortality and high fracture risk.
• 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 dynamic hip screw);
• Patient with a communicative ability to understand the procedure and participate in the study and the follow-up program.

You may not qualify if:

• Previous hip or pelvic fractures on the same side,
• Concurrent oral treatment with corticosteroids, and/or osteoporosis medication
• Irreversible coagulopathy or bleeding disorder. Note regarding reversible coagulopathies: Patients on coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants;
• Concurrent dialysis or elevated creatinine
• Hypo or hyper calcaemia
• Active treatment due to malignancy including ongoing or completed radiotherapy involving the pelvis/hip area,
• 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

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead
• Lund University Hospital: collaborator

Study Sites (1)

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, Lithuania

Location

Related Publications (1)

• Raina DB, Markeviciute V, Stravinskas M, Kok J, Jacobson I, Liu Y, Sezgin EA, Isaksson H, Zwingenberger S, Tagil M, Tarasevicius S, Lidgren L. A New Augmentation Method for Improved Screw Fixation in Fragile Bone. Front Bioeng Biotechnol. 2022 Mar 2;10:816250. doi: 10.3389/fbioe.2022.816250. eCollection 2022.

  PMID: 35309986 RESULT

Related Links

• Related Info

MeSH Terms

Interventions

Fracture Fixation, Internal; Zoledronic Acid

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sarunas Tarasevicius, MD,PhD

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 4, 2020
• Study Start: June 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 5-10 years after study finished.
• Access Criteria: Universities, hospitals and research institutions.

Locations

LI (1)