Care pathway for total knee replacement: a prospective single blind randomised controlled trial.
| ISRCTN | ISRCTN13043055 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13043055 |
| Secondary identifying numbers | N0050114601 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 22/08/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Professor Robert Newell
Scientific
Scientific
School of Health Studies
University of Bradford
Unity Building
25 Trinity Road
Bradford
BD5 0BB
United Kingdom
| Phone | +44 01274 236474 |
|---|---|
| r.j.newell@Bradford.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Are patients' outcomes improved by the use of a care pathway in total knee replacement? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 05/08/2002 |
| Completion date | 31/07/2003 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 100 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 05/08/2002 |
| Date of final enrolment | 31/07/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Health Studies
Bradford
BD5 0BB
United Kingdom
BD5 0BB
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Bradford Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
