Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510595
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Biomechanical Analysis of Distal Radius Greenstick Fracture Healing
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Biomechanical Analysis of Distal Radius Greenstick Fracture Healing by Finite Element Method
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 204 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
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 204 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None