Clinical trial NCT01293721: Study of Low-Magnitude, High-Frequency Vibration Treatment on Osteoporotic Hip Fracture Healing
Official title: Prospective Randomized Controlled Trial of the Efficacy of Low-Magnitude, High-Frequency Vibration Treatment on Osteoporotic Hip Fracture Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hip Fracture
Keywords: Bone Mineral Density
Vibration
Rehabilitation
Fracture healing rate
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2011-02-11
Enrollment: 72
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Fracture healing rate
timeFrame: up to 6 months
Secondary outcomes:
measure: Balancing ability
timeFrame: second month and sixth month post treatment
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Orthopaedics and Traumatology, The Chineses University of Hong Kong
name: Kwok Sui Leung, MD
role: PRINCIPAL_INVESTIGATOR
References: