Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
18/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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 measures

Blood loss & 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

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

Not Specified

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

Orthopaedics
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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes