Condition category
Musculoskeletal Diseases
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
28/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Andrew Roberts

ORCID ID

Contact details

Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Oswestry
Shropshire
SY10 7AG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4060

Study information

Scientific title

A randomised interventional treatment trial of the production of ankle-foot orthoses by laser scanning or existing methods in patients referred for rigid and hinged orthoses

Acronym

ABLE

Study hypothesis

The trial tests new technologies for producing ankle-foot orthoses (AFOs). AFOs are externally applied splints, usually customised to the particular needs of patients, the majority being children with neuromuscular conditions such as cerebral palsy that cause difficulties in controlling movement. The traditional method for producing orthotic devices involves the time-consuming use of plaster of Paris. This method often requires further fitting and adjustment of the orthosis after delivery to the patient.

Laser scanning with computer-aided design and manufacture (LSCAD/CAM) could enable a mould to be created much more quickly, accurately and cheaply once the equipment is purchased, thus helping the NHS to overcome a shortage of skilled orthotists. This technology is used widely in North America but has not yet been used in the NHS or adequately compared to the traditional method. ABLE is a randomised trial to estimate the costs to the NHS and benefits to patients of LSCAD/CAM comparing these with the present approach of creating moulds using plaster of Paris. While laser scanners offer the possibility of large potential benefits, the capital costs of LSCAD/CAM and costs of training orthotists in its use can be a deterrent to its purchase within the NHS. Our Trust provides one of the largest in-house orthotic services in the NHS and has recently acquired the LSCAD/CAM equipment.

If successful, the laser scanning system could be used for all types of orthoses currently produced by the traditional plastering method (e.g., spinal braces, head and neck orthoses, insoles and foot orthoses). A scanner may remove the need for return visits for re-casting because growth can be scaled into the first virtual cast and renewal orthoses can be sent by post. This technology could lead to greater integration and effectiveness of services at specialist orthotic centres where multidisciplinary teams can provide a strong clinical lead to the benefit of many patients.

Ethics approval

West Midlands REC Board approved on the 15/08/2007 (ref: 07/Q2604/85)

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal

Intervention

The intervention will include the production of a plaster cast and a virtual moulding using laser scanning with computer aided design and manufacture. Participants will experience both the plaster casting and scanning methods before being randomly allocated to have their AFO made from one of the two methods. The total duration of treatment is one of the outcomes of the study. The total duration of the study follow up is twelve months.

Study entry: single randomisation only

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Time from referral to delivery of ankle-foot orthoses

Secondary outcome measures

Health service and societal costs from referral for AFO to 12 months

Overall trial start date

26/02/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All patients up to 21 years of age, either sex, referred for rigid and hinged ankle-foot orthoses

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Planned sample size: 150; UK sample size: 150

Participant exclusion criteria

1. Do not consent to the study
2. Considered by the orthotist to be unsplintable
3. Unable to communicate directly or via a parent/carer
4. The AFO requested is the Saltiel type

Recruitment start date

26/02/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
Shropshire
SY10 7AG
United Kingdom

Sponsor information

Organisation

Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust (UK)

Sponsor details

Oswestry
Shropshire
SY10 7AG
United Kingdom
-
Teresa.jones@rjah.nhs.uk

Sponsor type

Not defined

Website

http://www.rjah.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/25336052

Publication citations

Additional files

Editorial Notes

28/10/2016: Publication reference added