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NCT Number: NCT01386749

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5days/week

Primary outcomes

  1. Time to radiologic healing

    Time frame: 1 year

    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 outcomes

  1. Functional outcomes

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 1, 2011
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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