Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Low-Magnitude, High Frequency Vibration Treatment on Femoral Shaft Fracture Healing

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Kwok-Sui Leung, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01386749
First received: June 22, 2011
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

Diaphyseal long bone fractures are usually associated with high energy trauma in which femoral shaft fracture is one common fracture in young age group. Surgery is usually needed for the diaphyseal lone bone fractures and the painful conditions always hinder weight bearing which is important for fracture healing and functional recovery. Fracture healing in cortical bone is less predictable than trabecular bone because they are less active and blood supply is more critical. Therefore accelerating fracture healing and rehabilitation of long bone fracture will absolutely bring significant economic benefit to the society in term of hospitalization and sick leave cost.

Low-magnitude, high-frequency vibration (LMHFV) treatment can provide systemic mechanical stimulation and is reported with multiple effects on musculoskeletal tissues. LMHFV can enhance the blood circulation and osteogenic effect in normal subjects and animals. Our previous clinical study also indicated that LMHFV could enhance the balancing ability and muscular function in normal post-menopausal women after treating whole-body vibration. For the fracture healing effect, an acceleration of healing by inducing callus formation and maturation in rat model was also reported in our previous studies.

In this study a total of 50 unilateral closed femoral shaft fracture patients of either gender aged 20-40 years old will be recruited and they will be randomized to either control and vibration group. The vibration group will be treated with LMHFV for 6 months. The findings of this study will provide very useful scientific data to support the application of LMHFV for fracture healing.


Condition Intervention Phase
Fracture, Closed, Comminuted, Healing
Procedure: vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Low-Magnitude, High Frequency Vibration Treatment on Accelerating the Healing of Femoral Shaft Fracture - A Prospective Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Time to radiologic healing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The healing time of fracture site among subjects is assessed by noting the time of appearance of the first bridging callus in x-ray film as well as the second bridging callus and the third bridging callus


Secondary Outcome Measures:
  • Functional outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The subjects are needed to perform functional outcome measurement according to our established protocol, including quality of life, muscle strength, balancing ability, vertical jump performance. The result of the above assessments will be reported as a scoring to show the functional performance and mobility of subjects.


Estimated Enrollment: 50
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: Treatment
receive 6 months LMHFV
Procedure: vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team
Stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5days/week

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or non-pregnant female aged 20-40 years old
  • patient with unilateral femoral shaft fracture
  • Fractures fixed with titanium intramedullary nail
  • patient able to comply with study protocol including follow evaluation

Exclusion Criteria:

  • open fracture
  • bilateral fracture
  • patient with multiple system injuries
  • fracture gap > 10mm
  • pathologic fracture
  • pregnant women
  • history of medication or disease affecting bone metabolism such as hypo- or hyperparathyroidism and hypo-, hyperthyroidism
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386749

Contacts
Contact: Kwok Sui Leung, MD 852 26322724 ksleung@cuhk.edu.hk
Contact: Wing Hoi Cheung, PhD 852 26321559 louis@ort.cuhk.edu.hk

Locations
China
Department of Orthopaedics and Traumatology , The Chinese University of Hong Kong Recruiting
Hong Kong, China
Contact: Kwok Sui Leung, MD    852 26322724    ksleung@cuhk.edu.hk   
Contact: Wing Hoi Cheung, PhD    852 26321559    louis@ort.cuhk.edu.hk   
Principal Investigator: Kwok Sui Leung, MD         
Sub-Investigator: Wing Hoi Cheung, PhD         
Sub-Investigator: James Griffith, FRCR         
Sub-Investigator: Ling Qin, PhD         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Kwok Sui Leung, MD Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Kwok-Sui Leung, Chair Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01386749     History of Changes
Other Study ID Numbers: 470410
Study First Received: June 22, 2011
Last Updated: April 23, 2012
Health Authority: Hong Kong: Department of Health
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Vibration treatment
Fracture healing
Muscular function

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Fractures, Closed
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014