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

Hip Fracture Clinical Trial

Official title:

Prospective Randomized Controlled Trial of the Efficacy of Low-Magnitude, High-Frequency Vibration Treatment on Osteoporotic Hip Fracture Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293721
• Other study ID #: 2008-KSWH
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 10, 2011
• Last updated: May 22, 2012
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of HealthHong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Device:
• Low-magnitude high - frequency vibration treatment
stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 7 days/week

Locations

Country	Name	City	State
China	Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fracture healing rate		up to 6 months	No
Secondary	Balancing ability		second month and sixth month post treatment	No