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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
  Purpose

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.


Condition Intervention Phase
Hip Fracture
 Device: Low-magnitude high - frequency vibration treatment
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial of the Efficacy of Low-Magnitude, High-Frequency Vibration Treatment on Osteoporotic Hip Fracture Healing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Fracture healing rate [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Balancing ability [ Time Frame: second month and sixth month post treatment ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: November 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
Experimental: Treatment
Receive vibration therapy
 Device: Low-magnitude high - frequency vibration treatment
stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 7 days/week

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293721

Locations
China
Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Kwok Sui Leung, MD Department of Orthopaedics and Traumatology, The Chineses University of Hong Kong
  More Information

No publications provided

Responsible Party: Kwok-Sui Leung, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01293721     History of Changes
Other Study ID Numbers: 2008-KSWH
Study First Received: February 10, 2011
Last Updated: May 22, 2012
Health Authority: Hong Kong: Department of Health
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Bone Mineral Density
Vibration
Rehabilitation
Fracture healing rate

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
 Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on June 17, 2013