Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
01/05/2015
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 GJ Shepard

ORCID ID

Contact details

Specialist Registrar
Orthopaedics
Royal Bolton Hospital
Farnworth
Bolton
BL4 0JR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

M0010095651

Study information

Scientific title

To determine the optimal resting leg position in the first 24 h following Total Knee Replacement (TKR) in terms of pain, swelling and restoration of function

Acronym

Study hypothesis

Not provided at time of registration

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 in this study will be randomised into either spending the first 24 h post-operatively with their operated leg on a Continuous Passive Motion (CPM) machine locked at 90 degrees or in an extension splint.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Pain, swelling and restoration of function

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2002

Overall trial end date

01/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

30 patients at the top of the department waiting list for total knee replacement

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

30

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2002

Recruitment end date

01/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Bolton Hospital
Bolton
BL4 0JR
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Bolton Hospitals 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