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Study of Low-Magnitude, High-Frequency Vibration Treatment on Osteoporotic Hip Fracture Healing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kwok-Sui Leung, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01293721
First received: February 10, 2011
Last updated: May 22, 2012
Last verified: May 2012
History of Changes

February 10, 2011
May 22, 2012
November 2011
May 2012   (final data collection date for primary outcome measure)
Fracture healing rate [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01293721 on ClinicalTrials.gov Archive Site
Balancing ability [ Time Frame: second month and sixth month post treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Low-Magnitude, High-Frequency Vibration Treatment on Osteoporotic Hip Fracture Healing
Prospective Randomized Controlled Trial of the Efficacy of Low-Magnitude, High-Frequency Vibration Treatment on Osteoporotic Hip Fracture Healing

Osteoporotic hip fracture is common in elderly. As a result of aging population in Hong Kong, the total number of hip fracture cases is anticipated to increase substantially in the future, and therefore draw more resources in hospitals and healthcare cost. Osteoporotic hip fracture usually causes severe pain and takes long time (4-8months) to recover due to impaired healing capability in osteoporotic bones and limited mobility. Consequently, the patients will recover very slowly as a result of low physical activities to provide inadequate mechanical stimulation. It is also known that mechanical, vascular and biological factors are the keys for fracture healing.

Low-magnitude, high-frequency vibration (LMHFV) treatment is a biophysical intervention to provide whole-body vibration signals for mechanical stimulation, which has been proven to be good in enhancing bone and muscle performance, as well as blood circulation. Our previous study of LMHFV on femoral fracture in rats showed acceleration of fracture healing, resulted from enhanced callus formation and maturation. Application of LMHFV on osteoporotic fractures could shorten the period of complete callus bridging by 30%. Our clinical trial on normal elderly also demonstrated improved muscle performance with good compliance, which is also a critical factor for fracture healing.

In this study, the investigators therefore hypothesize that LMHFV can enhance hip fracture healing by enhancing fracture impaction, maintaining bone mineral density, enhancing muscle recovery, thus improving implant mechanical stability and rehabilitation in elderly patients. The hip fracture elderly patient will be recruited and randomized into control or treatment group. They will be assessed on the fracture healing at fixed time point. The findings of this study will provide very useful scientific data to support the application of LMHFV for hip fracture patients.The ultimate goal is to enhance the fracture healing and rehabilitation in elderly patients.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Hip Fracture
Device: Low-magnitude high - frequency vibration treatment
stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 7 days/week
  • No Intervention: control
  • Experimental: Treatment
    Receive vibration therapy
    Intervention: Device: Low-magnitude high - frequency vibration treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • unilateral hip fracture patients older than 65 years old
  • patient fixed with dynamic hip screw

Exclusion Criteria:

  • unstable vital signs, large amount of drainage, or wound infection postoperatively
  • having of hormone replacement therapy or drug treatment known to affect bone metabolism or cause spontaneous bone loss
  • having hypo- or hyperparathyroidism and hypo-, hyperthyroidism, renal or liver disease
  • cannot tolerate or complication occurs during study
  • patients whose fracture is due to underlying disease, secondary to malignancy
Female
65 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01293721
2008-KSWH
No
Kwok-Sui Leung, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Kwok Sui Leung, MD Department of Orthopaedics and Traumatology, The Chineses University of Hong Kong
Chinese University of Hong Kong
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP