NCT01386749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

2.8 years

First QC Date

June 22, 2011

Last Update Submit

July 27, 2015

Conditions

Fracture, Closed, Comminuted, Healing

Keywords

Vibration treatmentFracture healingMuscular function

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Functional outcomes

    1 year

Study Arms (2)

Control

NO INTERVENTION

Treatment

EXPERIMENTAL

receive 6 months LMHFV

Procedure: vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team

Interventions

vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research teamPROCEDURE

Stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5days/week

Treatment

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics and Traumatology , The Chinese University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Fractures, BoneFractures, Comminuted

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Kwok Sui Leung, MD

    Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Professor

Study Record Dates

First Submitted

June 22, 2011

First Posted

July 1, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations

CN(1)