Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
27/09/2011
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 Mohamed El Masry

ORCID ID

Contact details

Flat 7
22 Park Row
Leeds
LS1 5HA
United Kingdom
+44 07974387455
drmedoelmasry@yahoo.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436165551

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the effectiveness of using a post operative drain following total knee replacement by directly measuring the amount of post operative bleeding using an ultrasound scan.

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

Musculoskeletal Diseases: Total knee replacement (TKR)

Intervention

Drains or no drains

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Post operative haematoma measured at 5 days post operation using an ultrasound scan

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2004

Overall trial end date

04/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients on the waiting list for total knee replacement (normal population)

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/2004

Recruitment end date

04/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Flat 7
Leeds
LS1 5HA
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 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

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20044678

Publication citations

  1. Results

    Omonbude D, El Masry MA, O'Connor PJ, Grainger AJ, Allgar VL, Calder SJ, Measurement of joint effusion and haematoma formation by ultrasound in assessing the effectiveness of drains after total knee replacement: A prospective randomised study., J Bone Joint Surg Br, 2010, 92, 1, 51-55, doi: 10.1302/0301-620X.92B1.22121.

Additional files

Editorial Notes