Fractures, BonePhase 1/2NCT06510595
Biomechanical Analysis of Distal Radius (Greenstick) Fracture Healing
A Phase 1/2 study testing Active Treatment Arm in people with Fractures, Bone, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Fractures, Bone
- What is being tested?
- Active Treatment Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 16 Jul 2024to 30 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child with green stick fracture in the distal third of radius bone.
- Child with immobilized brace or splint.
- Angle of fracture is ≤ 15 degrees.
Who cannot join
- The participants will be excluded from this study if they have one of the following:
- Other type of bone fracture.
- Osteoporotic bone.
- Neurological diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- 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.
- Conditions
- Fractures, Bone
- Being tested
- Active Treatment Arm, Control Treatment Arm
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Treatment ArmOther
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 ArmOther
The child will wear a brace as a conservative treatment method.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Arm | Experimental | The child will receive active elbow flexion exercise with electrotherapy. Receives: Other: Active Treatment Arm |
| Control Treatment Arm | Active comparator | The child will be managed with conservative treatment using a brace only. Receives: Other: Control Treatment Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Displacement and strain of fracture gap
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).
Measured: Followed up by x-ray weekly for 3:6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start16 Jul 2024 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Case-Control study 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.
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hassan Mohamed Hassan Elsheikh, University of Huddersfield
- Investigators
- Enas Youssif, Professor and Chairperson, Study chair, Musculoskeletal Disorders and its Surgery Faculty of Physical Therapy, Cairo University.Amr Imam, Professor, Study director, Applied Mathematics, Damanhour University.Ahmed Resk Mohammed, Assistant Professor, Study director, Department of Orthopedic Surgery, Faculty of Medicine, Cairo UniversityDina Abd Allah, Lecturer, Study director, Musculoskeletal Disorders and its Surgery Faculty of Physical Therapy, Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510595
- Sponsor's protocol ID
- P.T.REC/012/005143
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alierta JA, Perez MA, Garcia-Aznar JM. An interface finite element model can be used to predict healing outcome of bone fractures. J Mech Behav Biomed Mater. 2014 Jan;29:328-38. doi: 10.1016/j.jmbbm.2013.09.023. Epub 2013 Oct 8.
PubMed 24145150Augat P, Hollensteiner M, von Ruden C. The role of mechanical stimulation in the enhancement of bone healing. Injury. 2021 Jun;52 Suppl 2:S78-S83. doi: 10.1016/j.injury.2020.10.009. Epub 2020 Oct 2.
PubMed 33041020Bhavsar MB, Han Z, DeCoster T, Leppik L, Costa Oliveira KM, Barker JH. Electrical stimulation-based bone fracture treatment, if it works so well why do not more surgeons use it? Eur J Trauma Emerg Surg. 2020 Apr;46(2):245-264. doi: 10.1007/s00068-019-01127-z. Epub 2019 Apr 6.
PubMed 30955053Boland MR, Spigelman T, Uhl TL. The function of brachioradialis. J Hand Surg Am. 2008 Dec;33(10):1853-9. doi: 10.1016/j.jhsa.2008.07.019.
PubMed 19084189Cariati I, Bonanni R, Onorato F, Mastrogregori A, Rossi D, Iundusi R, Gasbarra E, Tancredi V, Tarantino U. Role of Physical Activity in Bone-Muscle Crosstalk: Biological Aspects and Clinical Implications. J Funct Morphol Kinesiol. 2021 Jun 21;6(2):55. doi: 10.3390/jfmk6020055.
PubMed 34205747Green JS, Williams SC, Finlay D, Harper WM. Distal forearm fractures in children:the role of radiographs during follow up. Injury. 1998 May;29(4):309-12. doi: 10.1016/s0020-1383(97)00208-8.
PubMed 9743754Gutierrez-Espinoza H, Rubio-Oyarzun D, Olguin-Huerta C, Gutierrez-Monclus R, Pinto-Concha S, Gana-Hervias G. Supervised physical therapy vs home exercise program for patients with distal radius fracture: A single-blind randomized clinical study. J Hand Ther. 2017 Jul-Sep;30(3):242-252. doi: 10.1016/j.jht.2017.02.001. Epub 2017 Mar 22.
PubMed 28342739Herrmann M, Engelke K, Ebert R, Muller-Deubert S, Rudert M, Ziouti F, Jundt F, Felsenberg D, Jakob F. Interactions between Muscle and Bone-Where Physics Meets Biology. Biomolecules. 2020 Mar 10;10(3):432. doi: 10.3390/biom10030432.
PubMed 32164381Khare D, Basu B, Dubey AK. Electrical stimulation and piezoelectric biomaterials for bone tissue engineering applications. Biomaterials. 2020 Nov;258:120280. doi: 10.1016/j.biomaterials.2020.120280. Epub 2020 Aug 7.
PubMed 32810650Kohata K, Itoh S, Takeda S, Kanai M, Yoshioka T, Suzuki H, Yamashita K. Enhancement of fracture healing by electrical stimulation in the comminuted intraarticular fracture of distal radius. Biomed Mater Eng. 2013;23(6):485-93. doi: 10.3233/BME-130774.
PubMed 24165551Lieber RL, Murray WM, Clark DL, Hentz VR, Friden J. Biomechanical properties of the brachioradialis muscle: Implications for surgical tendon transfer. J Hand Surg Am. 2005 Mar;30(2):273-82. doi: 10.1016/j.jhsa.2004.10.003.
PubMed 15781349Quadlbauer S, Pezzei C, Jurkowitsch J, Rosenauer R, Kolmayr B, Keuchel T, Simon D, Beer T, Hausner T, Leixnering M. Rehabilitation after distal radius fractures: is there a need for immobilization and physiotherapy? Arch Orthop Trauma Surg. 2020 May;140(5):651-663. doi: 10.1007/s00402-020-03367-w. Epub 2020 Mar 19.
PubMed 32193679Schmale GA, Mazor S, Mercer LD, Bompadre V. Lack of Benefit of Physical Therapy on Function Following Supracondylar Humeral Fracture: A Randomized Controlled Trial. J Bone Joint Surg Am. 2014 Jun 4;96(11):944-950. doi: 10.2106/JBJS.L.01696. Epub 2014 Jun 4.
PubMed 24897743
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Analysis of Distal Radius (Greenstick) Fracture Healing by Finite Element Method
- ClinicalTrials.gov ID
- NCT06510595
- Acronym / sponsor ID
- P.T.REC/012/005143
- Conditions
- Fractures, Bone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Jul 2024 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case-Control study 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.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Arm | Experimental | Other: Active Treatment ArmThe child will receive active elbow flexion exercise with electrotherapy. |
| Control Treatment Arm | Active comparator | Other: Control Treatment ArmThe child will be managed with conservative treatment using a brace only. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child with green stick fracture in the distal third of radius bone.
- Child with immobilized brace or splint.
- Angle of fracture is ≤ 15 degrees.
Key exclusion criteria (4 listed)
- Other type of bone fracture.
- Osteoporotic bone.
- Neurological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Treatment ArmElectrotherapy: 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. | Other | Active Treatment Arm |
| Control Treatment ArmThe child will wear a brace as a conservative treatment method. | Other | Control Treatment Arm |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Background: PubMed 24145150Alierta JA, Perez MA, Garcia-Aznar JM. An interface finite element model can be used to predict healing outcome of bone fractures. J Mech Behav Biomed Mater. 2014 Jan;29:328-38. doi: 10.1016/j.jmbbm.2013.09.023. Epub 2013 Oct 8.
- Background: PubMed 33041020Augat P, Hollensteiner M, von Ruden C. The role of mechanical stimulation in the enhancement of bone healing. Injury. 2021 Jun;52 Suppl 2:S78-S83. doi: 10.1016/j.injury.2020.10.009. Epub 2020 Oct 2.
- Background: PubMed 30955053Bhavsar MB, Han Z, DeCoster T, Leppik L, Costa Oliveira KM, Barker JH. Electrical stimulation-based bone fracture treatment, if it works so well why do not more surgeons use it? Eur J Trauma Emerg Surg. 2020 Apr;46(2):245-264. doi: 10.1007/s00068-019-01127-z. Epub 2019 Apr 6.
- Background: PubMed 19084189Boland MR, Spigelman T, Uhl TL. The function of brachioradialis. J Hand Surg Am. 2008 Dec;33(10):1853-9. doi: 10.1016/j.jhsa.2008.07.019.
- Background: PubMed 34205747Cariati I, Bonanni R, Onorato F, Mastrogregori A, Rossi D, Iundusi R, Gasbarra E, Tancredi V, Tarantino U. Role of Physical Activity in Bone-Muscle Crosstalk: Biological Aspects and Clinical Implications. J Funct Morphol Kinesiol. 2021 Jun 21;6(2):55. doi: 10.3390/jfmk6020055.
- Background: PubMed 9743754Green JS, Williams SC, Finlay D, Harper WM. Distal forearm fractures in children:the role of radiographs during follow up. Injury. 1998 May;29(4):309-12. doi: 10.1016/s0020-1383(97)00208-8.
- Background: PubMed 28342739Gutierrez-Espinoza H, Rubio-Oyarzun D, Olguin-Huerta C, Gutierrez-Monclus R, Pinto-Concha S, Gana-Hervias G. Supervised physical therapy vs home exercise program for patients with distal radius fracture: A single-blind randomized clinical study. J Hand Ther. 2017 Jul-Sep;30(3):242-252. doi: 10.1016/j.jht.2017.02.001. Epub 2017 Mar 22.
- Background: PubMed 32164381Herrmann M, Engelke K, Ebert R, Muller-Deubert S, Rudert M, Ziouti F, Jundt F, Felsenberg D, Jakob F. Interactions between Muscle and Bone-Where Physics Meets Biology. Biomolecules. 2020 Mar 10;10(3):432. doi: 10.3390/biom10030432.
- Background: PubMed 32810650Khare D, Basu B, Dubey AK. Electrical stimulation and piezoelectric biomaterials for bone tissue engineering applications. Biomaterials. 2020 Nov;258:120280. doi: 10.1016/j.biomaterials.2020.120280. Epub 2020 Aug 7.
- Background: PubMed 24165551Kohata K, Itoh S, Takeda S, Kanai M, Yoshioka T, Suzuki H, Yamashita K. Enhancement of fracture healing by electrical stimulation in the comminuted intraarticular fracture of distal radius. Biomed Mater Eng. 2013;23(6):485-93. doi: 10.3233/BME-130774.
- Background: PubMed 15781349Lieber RL, Murray WM, Clark DL, Hentz VR, Friden J. Biomechanical properties of the brachioradialis muscle: Implications for surgical tendon transfer. J Hand Surg Am. 2005 Mar;30(2):273-82. doi: 10.1016/j.jhsa.2004.10.003.
- Background: PubMed 32193679Quadlbauer S, Pezzei C, Jurkowitsch J, Rosenauer R, Kolmayr B, Keuchel T, Simon D, Beer T, Hausner T, Leixnering M. Rehabilitation after distal radius fractures: is there a need for immobilization and physiotherapy? Arch Orthop Trauma Surg. 2020 May;140(5):651-663. doi: 10.1007/s00402-020-03367-w. Epub 2020 Mar 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enas Youssif, Professor and Chairperson study chair
Musculoskeletal Disorders and its Surgery Faculty of Physical Therapy, Cairo University.
Amr Imam, Professor study director
Applied Mathematics, Damanhour University.
Ahmed Resk Mohammed, Assistant Professor study director
Department of Orthopedic Surgery, Faculty of Medicine, Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Active Treatment Arm in people with Fractures, Bone, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Elsheikh (07377613916, Mohamedhassan.elsheikh@hud.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Displacement and strain of fracture gap (time frame: Followed up by x-ray weekly for 3:6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06510595, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.