Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
01/03/2016
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 JH Newman

ORCID ID

Contact details

Winford Unit - AOC
North Bristol NHS Trust
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
+44 (0)117 959 3261
research@southmead.swest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0234088724

Study information

Scientific title

Trial of patellofemoral (PF) arthroplasty versus total knee joint replacement (TKR)

Acronym

Study hypothesis

To study the differences in patient based outcome measures, as a comparison between patellofemoral arthroplasty and total knee replacement in isolated osteoarthritis of the patellofemoral compartment.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Knee surgery

Intervention

Prospective randomised trial.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Patient based outcome measures to determine which type of prosthesis is best.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2000

Overall trial end date

30/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who are suitable for patellofemoral replacement and are on the waiting list for surgery. 50 Patients in each group aged over 50 years.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

100

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/10/2000

Recruitment end date

30/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Winford Unit - AOC
Bristol
BS10 5NB
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

Hospital/treatment centre

Funder name

North Bristol 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

01/03/2016: No publications found, verifying study status with principal investigator.