Total knee arthroplasty versus patellofemoral arthroplasty in patients with severe arthritis of the patellofemoral joint
| ISRCTN | ISRCTN34863373 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34863373 |
| Protocol serial number | AP1170 |
| Sponsors | University of Warwick, University Hospitals Coventry and Warwickshire NHS Trust (UK) |
| Funder | Action Medical Research (UK) |
- Submission date
- 20/08/2009
- Registration date
- 02/09/2009
- Last edited
- 28/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Juul Achten
Scientific
Scientific
Warwick Orthopaedics Research Manager
Clinical Sciences Research Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(s) | Coventry Research Ethics Committee, 03/03/2009, ref: 09/H1210/9 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Western Ontario and McMaster Osteoarthritis Index (WOMAC), used to determine knee function at 6 weeks, 3 months, 6 months and 12 months |
| Key secondary outcome measure(s) |
Measured pre-operatively, 3, 6 and 12 months post-operatively: |
| Completion date | 30/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 64 |
| Total final enrolment | 64 |
| Key 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 |
| Key exclusion criteria | 1. Unfit for an operation 2. Tibiofemoral arthritis of the knee |
| Date of first enrolment | 01/03/2009 |
| Date of final enrolment | 05/04/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Clinical Sciences Research Institute
Coventry
CV2 2DX
United Kingdom
CV2 2DX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/03/2020 | 28/07/2023 | Yes | No | |
| Protocol article | Protocol | 23/11/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/07/2023: Publication reference and total final enrolment added.
04/10/2017: Publication reference added.
