Biomechanical Analysis of Distal Radius (Greenstick) Fracture Healing

July 23, 2024 updated by: Mohamed Hassan Mohamed Hassan Elsheikh, Cairo University

Biomechanical Analysis of Distal Radius (Greenstick) Fracture Healing by Finite Element Method

The study will be conducted to investigate the effects of electrical charges (flexoelectric effect) & mechanical brachioradialis muscle bending force on the displacement and strain of fracture gap on children with Distal radius greenstick fracture via finite element method.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Distal radius fractures are common fractures and highly prevalent especially in children, due to skeletal immaturity. They may present as greenstick fractures; due to falling on the outstretched hand during sporting events.

This type of fracture causes deformation and angulation on the cortex layer of bone, while the other side remains intact due to the higher proportion of collagen and flexibility in immature bones, making them more prone to bending rather than breaking completely.

The biomechanical environment plays a dominant role in the process of fracture healing.

It controls the communication network of biological tissues and triggers the complex proliferation process.

This mechanical load is originated from muscle contraction along the axis of bone, which improves the healing process and accelerates the earlier return to weight bearing.

Likewise, the electrical stimulation plays a superior role in acceleration of bone healing. It enhances the cells migration and proliferation process, increases mineralization, and osteogenic genes activation. The bone minerals can generate electromechanical signals through the flexoelectricity effect, which they polarize in response to bending stress force.

While finite element method is an advanced technique and a promising field to simulate the mechanical properties and predict the biomechanical behaviors on the biological structures, no previous research took advantage of both flexoelectricity and mechanical principles to simulate and predict the healing behavior on specific case.

HYPOTHESES:

H0: There will be no significant effect of brachioradialis muscle bending force and flexoelectric effect on strain of distal radius greenstick fracture.

METHODOLOGY

  1. The study is analytical and will be conducted by (Finite Element Analysis) study with the following steps:

    • Modelling the radius fracture with angle ≤ 15 degrees.
    • Simulation the strain and displacement of fracture site by computerized mathematical equations with applying brachioradialis muscle force within 10-40 N and electrical charge.
  2. Validation the results of computerized simulation by experimental case-control study with the following steps.

Participants :

Child A: The child will receive active elbow flexion exercise with electrotherapy. Child B: The child will be managed by conservative treatment with brace only.

Instrumentation used in treatment:

Transcutaneous Electrical Nerve Stimulation (TENS) is a form of electrotherapy commonly used in physiotherapy to relieve pain. The setting will be adjusted on 2±0.4 Hz sinusoidal wave, pulse width is typically set between 50-200 microseconds and each session lasts between 20-30 minutes.

After the electrotherapy session, active assisted elbow flexion exercise will be applied with forearm in neutral position with 3 × 15 repetition to enhance the role of horizontal components of brachioradialis muscle force.

Study Type

Interventional

Enrollment (Estimated)

2

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Child with green stick fracture in the distal third of radius bone.
  • Child with immobilized brace or splint.
  • Angle of fracture is ≤ 15 degrees.

Exclusion criteria:

The participants will be excluded from this study if they have one of the following:

  • Other type of bone fracture.
  • Osteoporotic bone.
  • Neurological diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Treatment Arm
The child will receive active elbow flexion exercise with electrotherapy.
Other: Active Treatment Arm

Electrotherapy:

Transcutaneous Electrical Nerve Stimulation (TENS) will be placed across the fracture segments. The setting will be adjusted to 2±0.4 Hz sinusoidal wave, with a pulse width set between 50-200 microseconds, and each session will last between 20-30 minutes.

Active Elbow Flexion Exercise:

Following the electrotherapy session, the child will perform active assisted elbow flexion exercises with the forearm in a neutral position. This exercise will consist of 3 sets of 15 repetitions to enhance the role of the horizontal components of the brachioradialis muscle force.
Active Comparator: Control Treatment Arm
The child will be managed with conservative treatment using a brace only.
Other: Control Treatment Arm
The child will wear a brace as a conservative treatment method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Displacement and strain of fracture gap
Time Frame: Followed up by x-ray weekly for 3:6 weeks.
The angle of fracture displacement will be measured and followed up by x-ray weekly for 3:6 weeks. A reference line will be determined between proximal and distal points of the radial styloid with the fracture inclination line to identify the radial inclination angle (normal angle 22 -23 degrees).
Followed up by x-ray weekly for 3:6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Enas Youssif, Professor and Chairperson, Musculoskeletal Disorders and its Surgery Faculty of Physical Therapy, Cairo University.
  • Study Director: Amr Imam, Professor, Applied Mathematics, Damanhour University.
  • Study Director: Ahmed Resk Mohammed, Assistant Professor, Department of Orthopedic Surgery, Faculty of Medicine, Cairo University
  • Study Director: Dina Abd Allah, Lecturer, Musculoskeletal Disorders and its Surgery Faculty of Physical Therapy, Cairo University.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 16, 2024

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005143

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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