Clinical trial NCT01386749: Effect of Low-Magnitude, High Frequency Vibration Treatment on Femoral Shaft Fracture Healing
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Fracture, Closed, Comminuted, Healing
Keywords: Vibration treatment
Fracture healing
Muscular function
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2011-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Time to radiologic healing
timeFrame: 1 year
Secondary outcomes:
measure: Functional outcomes
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Orthopaedics and Traumatology , The Chinese University of Hong Kong
Study officials:
affiliation: Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
name: Kwok Sui Leung, MD
role: PRINCIPAL_INVESTIGATOR
References: