The Efficacy of Low-Magnitude, High Frequency Vibration Treatment on Accelerating the Healing of Femoral Shaft Fracture - A Prospective Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Time to radiologic healing
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control
Treatment
receive 6 months LMHFV
Intervention: vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team (Procedure)
Outcomes
Primary Outcomes
Time to radiologic healing
Time Frame: 1 year
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 Outcomes
- Functional outcomes(1 year)
Investigators
Kwok-Sui Leung
Chair Professor
Chinese University of Hong Kong