Effect of Low-Magnitude, High Frequency Vibration Treatment on Femoral Shaft Fracture Healing

Study Overview
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Brief Summary
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Diaphyseal long bone fractures are usually associated with high energy trauma in which femoral shaft fracture is one common fracture in young age group. Surgery is usually needed for the diaphyseal lone bone fractures and the painful conditions always hinder weight bearing which is important for fracture healing and functional recovery. Fracture healing in cortical bone is less predictable than trabecular bone because they are less active and blood supply is more critical. Therefore accelerating fracture healing and rehabilitation of long bone fracture will absolutely bring significant economic benefit to the society in term of hospitalization and sick leave cost. Low-magnitude, high-frequency vibration (LMHFV) treatment can provide systemic mechanical stimulation and is reported with multiple effects on musculoskeletal tissues. LMHFV can enhance the blood circulation and osteogenic effect in normal subjects and animals. Our previous clinical study also indicated that LMHFV could enhance the balancing ability and muscular function in normal post-menopausal women after treating whole-body vibration. For the fracture healing effect, an acceleration of healing by inducing callus formation and maturation in rat model was also reported in our previous studies. In this study a total of 50 unilateral closed femoral shaft fracture patients of either gender aged 20-40 years old will be recruited and they will be randomized to either control and vibration group. The vibration group will be treated with LMHFV for 6 months. The findings of this study will provide very useful scientific data to support the application of LMHFV for fracture healing.

Official Title
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The Efficacy of Low-Magnitude, High Frequency Vibration Treatment on Accelerating the Healing of Femoral Shaft Fracture - A Prospective Randomized Controlled Clinical Trial

Conditions
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Fracture, Closed, Comminuted, Healing

Intervention / Treatment
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* Procedure: vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or non-pregnant female aged 20-40 years old patient with unilateral femoral shaft fracture Fractures fixed with titanium intramedullary nail patient able to comply with study protocol including follow evaluation Exclusion Criteria: open fracture bilateral fracture patient with multiple system injuries fracture gap > 10mm pathologic fracture pregnant women history of medication or disease affecting bone metabolism such as hypo- or hyperparathyroidism and hypo-, hyperthyroidism

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Treatment<br>receive 6 months LMHFV | Procedure: vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team<br>* Stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5days/week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to radiologic healing | The healing time of fracture site among subjects is assessed by noting the time of appearance of the first bridging callus in x-ray film as well as the second bridging callus and the third bridging callus | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcomes | The subjects are needed to perform functional outcome measurement according to our established protocol, including quality of life, muscle strength, balancing ability, vertical jump performance. The result of the above assessments will be reported as a scoring to show the functional performance and mobility of subjects. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vibration treatment, Fracture healing, Muscular function