A prospective randomised trial of the use of tourniquet in total knee replacements
| ISRCTN | ISRCTN09327299 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09327299 |
| Secondary identifying numbers | N0244192302 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 21/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
Mr David Johnson
Scientific
Scientific
Orthopaedics
Aspen House
Stepping Hill Hospital
Poplar Grove
Stockport
SK2 7JE
United Kingdom
| David.Johnson@stockport.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A prospective randomised trial of the use of tourniquet in total knee replacements |
| Study objectives | To investigate the short-term outcomes of inflating the tourniquet only during the cementation process. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Total knee replacement (TKR) |
| Intervention | Intervention: Tourniquet only inflated during cementation of the replacement. Control: Tourniquet inflated throughout procedure as in routine practice. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Blood loss and change in haemoglobin level day 2 post-operatively |
| Secondary outcome measures | 1. Range of movement six weeks post-op 2. Post-operative wound problems 3. Operative time 4. Blood transfusion 5. Complication rate |
| Overall study start date | 01/11/2006 |
| Completion date | 01/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 252 |
| Key inclusion criteria | All patients undergoing total knee replacement at Stepping Hill Hospital under two named consultant surgeons |
| Key exclusion criteria | 1. History of peripheral vascular disease with absent popliteal or distal pulses 2. Calcification of artery on x-ray of knee 3. Previous vascular surgery on side of operation |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 01/11/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Stepping Hill Hospital
Stockport
SK2 7JE
United Kingdom
SK2 7JE
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Stockport NHS Foundation Trust
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 |
Editorial Notes
21/11/2019: No publications found. Verifying results with principal investigator.
06/02/2017: No publications found, verifying study status with principal investigator.
