Condition category
Musculoskeletal Diseases
Date applied
20/08/2009
Date assigned
02/09/2009
Last edited
04/06/2015
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 Juul Achten

ORCID ID

Contact details

Warwick Orthopaedics Research Manager
Clinical Sciences Research Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AP1170

Study information

Scientific title

The Warwick patellofemoral arthroplasty trial: a randomised clinical trial of total knee arthroplasty versus patellofemoral arthroplasty in patients with severe arthritis of the patellofemoral joint

Acronym

Study hypothesis

The objective of the study is to recruit 64 patients who are eligible for patellofemoral arthroplasty (PFA) and randomly assign these patients to either PFA or total knee arthroplasty (TKA).

The aims of the study are:
1. To quantify and draw inferences on observed differences in knee function for PFA and TKA at one-year post-operatively
2. To determine the complication rate of PFA versus TKA at one-year post-operatively
3. To investigate the cost effectiveness of PFA versus TKA

On 04/08/2011 the overall trial end date for this trial was extended from 31/12/2011 to 30/04/2013 to allow the team to achieve their target recruitment level.

Ethics approval

Coventry Research Ethics Committee, 03/03/2009, ref: 09/H1210/9

Study design

Single-centre randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Patellofemoral osteoarthritis

Intervention

All potential participants for this study will be identified by Orthopaedic Consultants in the arthroplasty clinics. Eligible patients will be randomised in a 1:1 allocation to a TKA or PFA. The patients allocated to TKA will have all of the surfaces of their knee joint replaced. The patients allocated to PFA will only have their patellofemoral articulation replaced. Both forms of treatment are well-established, but the exact details of the surgery will be left to the discretion of the surgeon in this pragmatic trial. The follow-up for both arms of the study will be equal: 12 months.

Further information can be obtained from:
Mr Matthew Costa
Clinical Sciences Research Institute
Clifford Bridge Road
Coventry CV2 2DX
United Kingdom
T: +44 (0)24 7696 8616
F: +44 (0)24 7696 8617

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Western Ontario and McMaster Osteoarthritis Index (WOMAC), used to determine knee function at 6 weeks, 3 months, 6 months and 12 months

Secondary outcome measures

Measured pre-operatively, 3, 6 and 12 months post-operatively:
1. UCLA Knee Rating Score
2. Oxford Knee Score
3. EuroQOl
4. Knee Society Score

Overall trial start date

01/03/2009

Overall trial end date

30/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Medically fit for an operation
2. Severe isolated patellofemoral osteoarthritis of the knee
3. Deemed suitable for a PFA by the consultant surgeon
4. Both male and female patients, aged 18 years and older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

64 patients

Participant exclusion criteria

1. Unfit for an operation
2. Tibiofemoral arthritis of the knee

Recruitment start date

01/03/2009

Recruitment end date

05/04/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Sciences Research Institute
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

University House
Coventry
CV4 8UW
United Kingdom

Sponsor type

University/education

Website

http://www2.warwick.ac.uk/fac/med/research/csri/

Organisation

University Hospitals Coventry and Warwickshire NHS Trust (UK)

Sponsor details

c/o Mrs Ceri Jones
Research and Development Department
University Hospital
1st Floor Rotunda
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Action Medical Research (UK)

Alternative name(s)

AMR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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