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

NCT ID: NCT01293721

Last Updated: 2012-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-05-31

Brief 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.

Conditions

Hip Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment

Receive vibration therapy

Group Type: EXPERIMENTAL

Low-magnitude high - frequency vibration treatment

Intervention Type: DEVICE

stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 7 days/week

Interventions

Low-magnitude high - frequency vibration treatment

stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 7 days/week

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Kwok-Sui Leung

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kwok Sui Leung, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Hong Kong, , China

Countries

China

Other Identifiers

2008-KSWH

Identifier Type: -

Identifier Source: org_study_id