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

Primary Purpose

Fracture, Closed, Comminuted, Healing

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture, Closed, Comminuted, Healing focused on measuring Vibration treatment, Fracture healing, Muscular function

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Orthopaedics and Traumatology , The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Treatment

Arm Description

receive 6 months LMHFV

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 22, 2011
Last Updated
July 27, 2015
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01386749
Brief Title
Effect of Low-Magnitude, High Frequency Vibration Treatment on Femoral Shaft Fracture Healing
Official Title
The Efficacy of Low-Magnitude, High Frequency Vibration Treatment on Accelerating the Healing of Femoral Shaft Fracture - A Prospective Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture, Closed, Comminuted, Healing
Keywords
Vibration treatment, Fracture healing, Muscular function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Treatment
Arm Type
Experimental
Arm Description
receive 6 months LMHFV
Intervention Type
Procedure
Intervention Name(s)
vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team
Intervention Description
Stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5days/week
Primary Outcome Measure Information:
Title
Time to radiologic healing
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Functional outcomes
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwok Sui Leung, MD
Organizational Affiliation
Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedics and Traumatology , The Chinese University of Hong Kong
City
Hong Kong
Country
China

12. IPD Sharing Statement

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

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