Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes