Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
14/11/2014
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 D J Kramer

ORCID ID

Contact details

Orthopaedic Department
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
+44 (0)191 259 6660

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0504095061

Study information

Scientific title

Acronym

Study hypothesis

Trial of gun application vs finger loading of cement for cementation of tibial component in primary total knee replacement

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

Patients undergoing total knee replacement surgery will be randomised into two groups.

Group A will have their knee replacement implanted using the current technique of finger packing cement into bone for the femoral component and loading the tibial tray with cement before impaction of the tibial implant.

Group B will have cement applied while still liquid to the tibial plateau using the cement gun before application of the tibial component. Other aspects of bone preparation and cementing will remain unchanged, including use of pulsed lavage and hydrogen peroxide. Initial outcome will be assessed according to radiolucent lines on post-operative radiographs.

Assessments will be performed by a single observer (RKP), blinded to the patients' group allocation.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Long-term outcome will be assessed after 10 years prospective follow-up - revision rate

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2000

Overall trial end date

30/05/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients undergoing primary total knee replacement for osteoarthritis
2. Males and female inpatients

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

30 subjects and 30 controls

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2000

Recruitment end date

30/05/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Orthopaedic Department
North Shields
NE29 8NH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Northumbria Healthcare NHS Trust (UK)

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