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

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

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.

Study Overview

• Status: Completed
• Conditions: Fracture, Closed, Comminuted, Healing
• Intervention / Treatment: Procedure: vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Treatment; receive 6 months LMHFV	Procedure: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Kwok Sui Leung, MD, Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 22, 2011
• First Submitted That Met QC Criteria: June 30, 2011
• First Posted (Estimate): July 1, 2011

Study Record Updates

• Last Update Posted (Estimate): July 29, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Fracture healing; Vibration treatment; Muscular function
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Closed
• Other Study ID Numbers: 470410