Biomechanical Analysis of Distal Radius (Greenstick) Fracture Healing

NCT06510595 | Not Yet Recruiting Phase 1

• 1 other identifier: P.T.REC/012/005143
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fractures, Bone

Outcome Measures

Primary Outcomes (1)

• 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).

  Followed up by x-ray weekly for 3:6 weeks.

Study Arms (2)

Active Treatment Arm

EXPERIMENTAL

The child will receive active elbow flexion exercise with electrotherapy.

Other: Active Treatment Arm

Control Treatment Arm

ACTIVE COMPARATOR

The child will be managed with conservative treatment using a brace only.

Other: Control Treatment Arm

Interventions

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.

Active Treatment Arm

Control Treatment Arm OTHER

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

Control Treatment Arm

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• The participants will be excluded from this study if they have one of the following:
• Other type of bone fracture.
• Osteoporotic bone.
• Neurological diseases.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (13)

• 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.

  PMID: 24145150 BACKGROUND

• Augat 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.

  PMID: 33041020 BACKGROUND

• Bhavsar 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.

  PMID: 30955053 BACKGROUND

• Boland 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.

  PMID: 19084189 BACKGROUND

• Cariati 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.

  PMID: 34205747 BACKGROUND

• Green 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.

  PMID: 9743754 BACKGROUND

• Gutierrez-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.

  PMID: 28342739 BACKGROUND

• Herrmann 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.

  PMID: 32164381 BACKGROUND

• Khare 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.

  PMID: 32810650 BACKGROUND

• Kohata 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.

  PMID: 24165551 BACKGROUND

• Lieber 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.

  PMID: 15781349 BACKGROUND

• Quadlbauer 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.

  PMID: 32193679 BACKGROUND

• Schmale 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.

  PMID: 24897743 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Enas Youssif, Professor and Chairperson

  Musculoskeletal Disorders and its Surgery Faculty of Physical Therapy, Cairo University.

  STUDY CHAIR

• 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.

  STUDY DIRECTOR

Central Study Contacts

Mohamed Elsheikh

CONTACT

07377613916; Mohamedhassan.elsheikh@hud.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 19, 2024
• Study Start: July 16, 2024
• Primary Completion: January 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07