We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01293721
First Posted: February 11, 2011
Last Update Posted: May 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kwok-Sui Leung, Chinese University of Hong Kong
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


Further study details as provided by Kwok-Sui Leung, Chinese University of Hong Kong:

Primary Outcome Measures:
  • Fracture healing rate [ Time Frame: up to 6 months ]

Secondary Outcome Measures:
  • Balancing ability [ Time Frame: second month and sixth month post treatment ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kwok-Sui Leung, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01293721     History of Changes
Other Study ID Numbers: 2008-KSWH
First Submitted: February 10, 2011
First Posted: February 11, 2011
Last Update Posted: May 23, 2012
Last Verified: May 2012

Keywords provided by Kwok-Sui Leung, 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