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

Primary Purpose

Hip Fracture

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Low-magnitude high - frequency vibration treatment
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring Bone Mineral Density, Vibration, Rehabilitation, Fracture healing rate

Eligibility Criteria

65 Years - 85 Years (Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

Treatment

Arm Description

Receive vibration therapy

Outcomes

Primary Outcome Measures

Fracture healing rate

Secondary Outcome Measures

Balancing ability

Full Information

First Posted
February 10, 2011
Last Updated
May 22, 2012
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01293721
Brief Title
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

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
Bone Mineral Density, Vibration, Rehabilitation, Fracture healing rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Receive vibration therapy
Intervention Type
Device
Intervention Name(s)
Low-magnitude high - frequency vibration treatment
Intervention Description
stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 7 days/week
Primary Outcome Measure Information:
Title
Fracture healing rate
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Balancing ability
Time Frame
second month and sixth month post treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwok Sui Leung, MD
Organizational Affiliation
Department of Orthopaedics and Traumatology, The Chineses University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
City
Hong Kong
Country
China

12. IPD Sharing Statement

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

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