Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
19/10/2012
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 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

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

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

  1. 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.

Additional files

Editorial Notes