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

ISRCTN	ISRCTN87522845
DOI	https://doi.org/10.1186/ISRCTN87522845
Protocol serial number	N0034136470
Sponsor	Department of Health
Funder	Barnsley District General Hospital NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr Jonathan McGregor-Riley
Scientific

Barnsley Hospital
Barnsley
S75 2EP
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Is a neutralisation plate always necessary in the treatment of unstable ankle fractures?
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Injury, Occupational Diseases, Poisoning: Ankle fractures
Intervention	Neutralisation plate vs standard practice
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Efficacy of treatment
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/04/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Key inclusion criteria	All adults over 18 years of age admitted to this Trust will be randomised.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/2002
Date of final enrolment	01/04/2005

Barnsley Hospital

Barnsley
S75 2EP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan