Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
16/12/2014
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 Jonathan McGregor-Riley

ORCID ID

Contact details

Barnsley Hospital
Barnsley
S75 2EP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0034136470

Study information

Scientific title

Is a neutralisation plate always necessary in the treatment of unstable ankle fractures?

Acronym

Study hypothesis

To ascertain whether the avoidance of a plate will minimise soft tissue problems and lateral hardware associated pain and hence reduce the need for the removal of metalwork whilst maintaining adequate fracture fixation

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Injury, Occupational Diseases, Poisoning: Ankle fractures

Intervention

Neutralisation plate vs standard practice

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Efficacy of treatment

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2002

Overall trial end date

01/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All adults over 18 years of age admitted to this Trust will be randomised.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2002

Recruitment end date

01/04/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barnsley Hospital
Barnsley
S75 2EP
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Barnsley District General Hospital NHS Trust (UK)

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

Publication citations

Additional files

Editorial Notes