Contact information
Type
Scientific
Primary contact
Mr David Johnson
ORCID ID
Contact details
Orthopaedics
Aspen House
Stepping Hill Hospital
Poplar Grove
Stockport
SK2 7JE
United Kingdom
-
David.Johnson@stockport.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0244192302
Study information
Scientific title
A prospective randomised trial of the use of tourniquet in total knee replacements
Acronym
Study hypothesis
To investigate the short-term outcomes of inflating the tourniquet only during the cementation process.
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
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/11/2006
Overall trial end date
01/11/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients undergoing total knee replacement at Stepping Hill Hospital under two named consultant surgeons
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
252
Participant 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
Recruitment start date
01/11/2006
Recruitment end date
01/11/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Stepping Hill Hospital
Stockport
SK2 7JE
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Stockport NHS Foundation Trust
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
Basic results (scientific)
Publication list