ISRCTN ISRCTN66721986
DOI https://doi.org/10.1186/ISRCTN66721986
Secondary identifying numbers N0284126103
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
19/10/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Peter Wood
Scientific

Wrightington, Wigan & Leigh NHS Trust, Wright
Wrightington Hospital
Hall Lane
Appley Bridge
Wigan
WN6 9EP
United Kingdom

Email peter.wood@wiganlhs-tr.nwest.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo compare the long term performance of ankle joint replacements - STAR and BP. Current literature states that there is no long term difference between the two prosthesis
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Ankle replacement
InterventionLong term follow up, in terms of range of motion, x-ray assessment and gait analysis on selected patients. Recruit over two years and follow up for 10 years
Intervention typeProcedure/Surgery
Primary outcome measureA long term clinical comparison of two ankle replacements
Secondary outcome measuresNot provided at time of registration
Overall study start date03/01/2000
Completion date03/01/2010

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients with Scandinavian Total Ankle Replacement (STAR) and Buechel-Pappas (BP) total ankle replacements
Key exclusion criteriaNot provided at time of registration
Date of first enrolment03/01/2000
Date of final enrolment03/01/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Wrightington, Wigan & Leigh NHS Trust, Wright
Wigan
WN6 9EP
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

Wrightington, Wigan and Leigh NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2009 Yes No