Contact information
Type
Scientific
Primary contact
Professor Robert Newell
ORCID ID
Contact details
School of Health Studies
University of Bradford
Unity Building
25 Trinity Road
Bradford
BD5 0BB
United Kingdom
+44 01274 236474
r.j.newell@Bradford.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0050114601
Study information
Scientific title
Acronym
Study hypothesis
Are patients' outcomes improved by the use of a care pathway in total knee replacement?
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Total knee replacement (TKR)
Intervention
A prospective randomised controlled trial of a care pathway for a total knee replacement versus current best clinical care. It is not possible for clinical staff to be blind to the condition in which they are participating. However, we contend that patients will be unaware of whether a care pathway is a novel organisation of care and so will be unaware of whether they have been allocated to the novel or usual treatment condition.
Added September 2008: trial stopped in August 2004 as wards within the hospital were reconfigured which meant randomisation was not possible.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
The main outcome measure will be length of stay in hospital.
Secondary outcome measures
Secondary measures will be: adequacy of pain control, readmission rate and patient satisfaction as measured by an audit tool currently used within the Trust.
Overall trial start date
05/08/2002
Overall trial end date
31/07/2003
Reason abandoned
Objectives no longer viable
Eligibility
Participant inclusion criteria
100 women undergoing knee replacement surgery in Bradford Royal Infirmary Wards 3 and 5 who consent to participate in the study. Confining the study to women allows us to randomise between the two local settings, since only one setting deals with both sexes. 69% of knee replacement operations within the Trust are female. This percentage also reflects national and international trends. Mean age locally for this procedure is 69 years.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
05/08/2002
Recruitment end date
31/07/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Health Studies
Bradford
BD5 0BB
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Bradford Hospitals 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