Contact information
Type
Scientific
Primary contact
Mr Peter Wood
ORCID ID
Contact details
Wrightington
Wigan & Leigh NHS Trust
Wright
Wrightington Hospital
Hall Lane
Appley Bridge
Wigan
WN6 9EP
United Kingdom
peter.wood@wiganlhs-tr.nwest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0284126103
Study information
Scientific title
Acronym
Study hypothesis
To 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
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
Surgery: Ankle replacement
Intervention
Long 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 type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
A long term clinical comparison of two ankle replacements
Secondary outcome measures
Not provided at time of registration
Overall trial start date
03/01/2000
Overall trial end date
03/01/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with Scandinavian Total Ankle Replacement (STAR) and Buechel-Pappas (BP) total ankle replacements
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
03/01/2000
Recruitment end date
03/01/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wrightington, Wigan & Leigh NHS Trust, Wright
Wigan
WN6 9EP
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Wrightington, Wigan and Leigh 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
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19092007
Publication citations
-
Results
Wood PL, Sutton C, Mishra V, Suneja R, A randomised, controlled trial of two mobile-bearing total ankle replacements., J Bone Joint Surg Br, 2009, 91, 1, 69-74, doi: 10.1302/0301-620X.91B1.21346.