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NCT Number: NCT06510595

Biomechanical Analysis of Distal Radius (Greenstick) Fracture Healing

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.

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Key information

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Treatment Arm

Other

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.

Control treatment arm

Other

The child will wear a brace as a conservative treatment method.

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Elsheikh

CONTACT

[email protected]

07377613916

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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