Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
24/08/2015
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

Dr N Shaath

ORCID ID

Contact details

Barnsley District General Hospital
Orthipaedics Dept
Gawber Rd
Barnsley
S752EP
United Kingdom
+44 (0)1226 730000
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0034162610

Study information

Scientific title

Study of the difference in outcomes between two treatment modalities of the patella in total knee replacement

Acronym

Study hypothesis

To compare the outcomes of two types of surgical procedures used to manage the patella during total knee replacement (TKR) by assessing: anterior knee pain, radiographs of the patella, post-operative range of movement, score as measured by the American Knee Society clinical rating system.

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

Musculoskeletal Diseases: Total knee replacement (TKR)

Intervention

Randomised prospective study

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

To ascertain the outcomes of these two treatment modalities in terms of function. This may lead to a change of practice at BHNFT and nationwide if the results of one procedure are found to be significantly better than the other.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2005

Overall trial end date

01/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

100 patients (undergoing cemented or uncemented Corin rotaglide total knee replacement to treat osteoarthritis)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2005

Recruitment end date

01/11/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barnsley District General Hospital
Barnsley
S75 2EP
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

Barnsley Hospital NHS Foundation 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