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

NCT ID: NCT01386749

Last Updated: 2015-07-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-12-31

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.

Detailed Description

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Conditions

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Fracture, Closed, Comminuted, Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment

receive 6 months LMHFV

Group Type EXPERIMENTAL

vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Kwok-Sui Leung

Chair Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

Other Identifiers

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470410

Identifier Type: -

Identifier Source: org_study_id

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