Vibration as a Method of Fracture Screening in Children

NCT04643912 | Completed

• 1 other identifier: SCH/13/053b
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

When assessing an injured child, doctors must decide whether or not there is an underlying bone fracture. The best way of doing this is to take an x-ray. In 2011, the 46,000 children attending Sheffield Children's Hospital Emergency Department had 10,400 x-rays mainly to help diagnose fractures. Taking just the foot and wrist, 2,215 x-rays were normal with no fracture, at a cost of £119,610 for the Sheffield community alone (at tariff £54 per x-ray). This works out as a cost of approximately £12 million per year across England and Wales. Additionally, although the radiation dose is quite small, given that x-rays can cause cancer, no radiation is better than some radiation. A fracture screening method is needed that will help doctors, schoolteachers and others more reliably decide which children should have an x-ray. Vibration is reliably used in industry to find defects such as cracks in machines and other structures. The researchers believe that vibration can similarly find fractures in bones in children. The team has recently demonstrated the ability of vibration to correctly pick the 3 x-ray confirmed cases out of 13 adults who had a wrist fracture (7 healthy adults and 6 with wrist injury). None of the 6 injured adults felt that vibration would be too painful to use on injured children. The proposal is now to compare the vibration patterns of the bones of about 150 children over 10 years of age attending the researchers' Emergency Department with their fracture positive or fracture negative x-rays. The researchers also propose to assess any differences in the vibration patterns between left and right wrist and ankles in 50 healthy school children with no injury. Should vibration analysis for fracture screening prove sufficiently accurate, further larger studies shall be conducted, with the aim of developing an instrument that will reduce the number of injured children having unnecessary x-rays. On completion of this study, the plan is to extend the study to include younger children. This will lead to cost savings for the NHS and less inconvenience for patients and their families, with shorter stays in Emergency Departments and reduced population exposure to harmful ionising radiation.

Conditions

Bone Fracture

Keywords

Medical device; Vibration

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of vibration analysis for detecting wrist and ankle fractures

  Number of patients correctly stratified by vibration analysis into fracture and non-fracture groups (reference standard = wrist/ankle radiographs)

  4 years

Study Arms (1)

Injured wrist or ankle

EXPERIMENTAL

Child with trauma needing wrist or ankle x-ray: Will receive vibration analysis blinded to x-ray findings.

Diagnostic Test: Vibration Device

Interventions

Vibration Device DIAGNOSTIC_TEST

Device which causes the bone to vibrate and records the spectrum of that vibration

Injured wrist or ankle

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Age 9 years and 364 days or less. Age 16 years or more
• Injury sustained more than 24 hours before attendance
• Informed consent withheld
• Distressed child or family (most children will receive pain relief in the Emergency Department prior to having their radiographs and vibration analysis)
• Both arms or both legs thought to be fractured (the non-fractured contralateral limb will act as control for each child)
• Inability to access bony prominence
• Presence of metal work (e.g. internal or external fixators), plaster of Paris or other cast
• Previously recorded fracture or orthopaedic surgery (this might affect vibration spectra).
• Healthy Controls We have previously obtained a letter of support from the Deputy Head of King Edward's VII Language College, Sheffield, to recruit 20 healthy children and perform vibration analysis at a convenient time (11.00am to 1.00pm on Saturdays). We have so far recruited 15 healthy children and will seek permission from the Head/Deputy Head to extend the original 20 to 50.
• Age 9 years and 364 days or less. Age 16 years or more
• Previous fracture to any wrist or ankle
• Previous surgery to any wrist or ankle
• Known chronic disease (any long-term disease on-going for over one year)
• Informed consent withheld
• Inability to access bony prominence

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

Study Sites (1)

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), S10 2TH, United Kingdom

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Amaka Offiah, BSc,MBBS,PhD

  Sheffield Children's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Measuring the effectiveness of vibration fracture analysis against standard radiographs.

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 25, 2020
• Study Start: October 7, 2016
• Primary Completion: May 28, 2017
• Study Completion: January 6, 2020
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)