Hip FracturePhase 2/3NCT01293721
Study of Low-Magnitude, High-Frequency Vibration Treatment on Osteoporotic Hip Fracture Healing
A Phase 2/3 study testing Low-magnitude high - frequency vibration treatment in people with Hip Fracture, run by Chinese University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years, women only
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Low-magnitude high - frequency vibration treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to May 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- unilateral hip fracture patients older than 65 years old
- patient fixed with dynamic hip screw
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
Hong Kong
About this study
Official title: Prospective Randomized Controlled Trial of the Efficacy of Low-Magnitude, High-Frequency Vibration Treatment on Osteoporotic Hip Fracture Healing
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
- Being tested
- Low-magnitude high - frequency vibration treatment
- Keywords
- Bone Mineral Density, Vibration, Rehabilitation, Fracture healing rate
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-magnitude high - frequency vibration treatmentDevice
stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 7 days/week
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| Treatment | Experimental | Receive vibration therapy Receives: Device: Low-magnitude high - frequency vibration treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture healing rate
Measured: up to 6 months
Secondary outcomes (1)
Balancing ability
Measured: second month and sixth month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwok-Sui Leung, Chinese University of Hong Kong
- Investigators
- Kwok Sui Leung, MD, Principal investigator, Department of Orthopaedics and Traumatology, The Chineses University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293721
- Sponsor's protocol ID
- 2008-KSWH
- Status last verified
- May 2012
- First submitted
- 10 Feb 2011
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial of the Efficacy of Low-Magnitude, High-Frequency Vibration Treatment on Osteoporotic Hip Fracture Healing
- ClinicalTrials.gov ID
- NCT01293721
- Acronym / sponsor ID
- 2008-KSWH
- Conditions
- Hip Fracture
- Keywords
- Bone Mineral Density, Vibration, Rehabilitation, Fracture healing rate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| Treatment | Experimental | Device: Low-magnitude high - frequency vibration treatmentReceive vibration therapy |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- unilateral hip fracture patients older than 65 years old
- patient fixed with dynamic hip screw
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-magnitude high - frequency vibration treatmentstand on a vibration platform at 35Hz, 0.3g, 20mins/day and 7 days/week | Device | Treatment |
Primary outcome
Fracture healing rate
Time frame: up to 6 months
1 secondary outcome
Balancing ability
Time frame: second month and sixth month post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwok Sui Leung, MD principal investigator
Department of Orthopaedics and Traumatology, The Chineses University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Low-magnitude high - frequency vibration treatment in people with Hip Fracture, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture healing rate (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2012.