Fracture, Closed, Comminuted, Healing Clinical Trial
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
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 40 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Orthopaedics and Traumatology , The Chinese University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to radiologic healing | 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 | 1 year | No |
Secondary | Functional outcomes | 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. | 1 year | No |
Status | Clinical Trial | Phase | |
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