Effect of Low-Magnitude, High Frequency Vibration Treatment on Femoral Shaft Fracture Healing
NCT ID: NCT01386749
Last Updated: 2015-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
50 participants
INTERVENTIONAL
2011-02-28
2013-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control
No interventions assigned to this group
Treatment
receive 6 months LMHFV
vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team
Stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5days/week
Interventions
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vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team
Stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5days/week
Eligibility Criteria
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Inclusion Criteria
* patient with unilateral femoral shaft fracture
* Fractures fixed with titanium intramedullary nail
* patient able to comply with study protocol including follow evaluation
Exclusion Criteria
* 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
20 Years
40 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Kwok-Sui Leung
Chair Professor
Principal Investigators
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Kwok Sui Leung, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
Locations
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Department of Orthopaedics and Traumatology , The Chinese University of Hong Kong
Hong Kong, , China
Countries
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Other Identifiers
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470410
Identifier Type: -
Identifier Source: org_study_id
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