Should we replace the back of the knee cap all of the time or some of the time in patients having knee replacement surgery? A trial comparing patient outcomes and the cost to the NHS.
| ISRCTN | ISRCTN33276681 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33276681 |
| IRAS number | 320677 |
| Secondary identifying numbers | CPMS 54796, NIHR131850, IRAS 320677 |
- Submission date
- 13/02/2023
- Registration date
- 27/02/2023
- Last edited
- 04/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Improving pain and mobility after total knee replacement (TKR) surgery has been highlighted as a research priority by patients. TKR surgery is common. 109,000 are carried out every year in the UK. It is performed to help patients with pain from disabling arthritis.
TKR involves replacing the bottom of the thighbone (femur) and the top of the leg bone (tibia) with artificial implants. Surgeons also decide on one of two options for treating the kneecap:
1) The kneecap (patella) is not changed.
2) The surgeon attaches a separate artificial implant to the back of the kneecap, which may reduce further wear or pain. This is known as resurfacing the kneecap.
National guidance is that always resurfacing is better than never resurfacing.
Many surgeons make an individual choice about whether to resurface the kneecap. This is based on factors such as pain and the condition of the kneecap. We call this selective resurfacing.
Our study will compare patients undergoing TKR who all have the kneecap resurfaced with those who have it selectively resurfaced.
Who can participate?
Over 4 years we will recruit 530 patients having TKR at 15 or more NHS England hospitals.
What does the study involve?
Participants will be randomly split into two equal groups of 265. All patients in one group will have their kneecap resurfaced. In the other, the surgeon will decide during the operation whether or not to resurface the kneecap.
All other aspects of care will be the same. Follow-up questionnaires at 3-, 6- and 12 months after surgery will be completed. The questionnaires collect data on quality of life, symptoms and pain in the knee, complications of surgery, need for further surgery, and costs to the NHS and patients.
This will find out which strategy gives better outcomes for patients, and whether one is better value for money for the NHS.
What are the possible benefits and risks of participating?
The surgical intervention of interest in this study is replacing the knee cap (also known as patellar resurfacing) some of the time, compared with the current standard of care recommended by national authorities (NICE) which is performing patellar resurfacing all of the time. NICE guidance states that patellar resurfacing is not associated with safety concerns. Therefore patellar resurfacing during knee replacement is a commonly used procedure which poses no additional risks to routine care.
Study procedures will include questionnaires at each listed time point. All other study assessments will require participant’s time, however no other inconvenience or risk is expected above that of routine care and follow-up.
There is unlikely to be any direct benefit as a result of participation in the study. Investigation of whether to utilise patellar resurfacing in patients with knee arthritis all of the time or some of the time will help to inform future treatment of patients undergoing primary total knee replacement surgery and could result in reduced costs for the NHS. The main benefit of this study is the provision of high-quality evidence to address this important area of clinical uncertainty that has been highlighted by NICE in their recent evidence publication.
Where is the study run from?
North Bristol NHS Trust (UK)
When is the study starting and how long is it expected to run for?
April 2022 to March 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
PART-trial@bristol.ac.uk
Contact information
Scientific
University of Sheffield
Barber House
387 Glossop Road
Sheffield
S10 2HQ
United Kingdom
 ORCID ID |
0000-0002-9940-1095 |
|---|---|
| Phone | +44 114 2228714 |
| a.blom@sheffield.ac.uk |
Scientific
Sheffield Teaching Hospitals NHS Foundation Trust
Sheff
-
United Kingdom
| michael.petrie@nhs.net |
Public
University of Bristol
Bristol Trials Centre
1-5 Whiteladies Road
Bristol
BS8 1NU
United Kingdom
| PART-trial@bristol.ac.uk |
Study information
| Study design | Interventional multicentre pragmatic parallel two-group superiority randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 43206 PART PIS v2.0 08.02.23.pdf |
| Scientific title | The clinical and cost-effectiveness of elective primary total knee replacement with PAtellar Resurfacing compared to selective patellar resurfacing. A pragmatic multicentre randomised controlled Trial with blinding (PART) |
| Study hypothesis | Following primary total knee replacement, there will be no difference in the mean Oxford Knee Score at 1 year postoperatively in patients who have undergone patellar resurfacing compared with those who have undergone selective patellar resurfacing. |
| Ethics approval(s) |
Approved 16/01/2023, Wales REC 2 (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)7920 565664; Wales.REC2@wales.nhs.uk), ref: 22/WA/0367 |
| Condition | Total knee replacement with patellar resurfacing compared to selective patellar resurfacing |
| Intervention | Randomisation: Randomisation will be carried out intraoperatively once total knee replacement has been performed and the size of the patella can be measured. Participants will be allocated in a 1:1 ratio to either always patella resurfacing or selective patella resurfacing. Intervention/Health technologies being assessed: Experimental: Selective resurfacing of the patella based on pre-operative factors such as pain and function and intraoperative assessment of the patella by surgeons. Control: Always resurfacing of the aptella Follow up: Participants who agree to participate in the study will be followed up at approximately 3, 6, and 12 months postrandomisation for information on knee function, activity, HRQoL (Health Related Quality of Life), return to work and resource use. If further funding is awarded, patients will be followed up for a total of ten years. Patients may be contacted via phonecall, text message or email. In the event that unforeseen circumstances prevent sites from being able to carry out their normal activities, they should contact the Bristol Trials Centre (BTC) who will do everything they can to help. This may include, but is not limited to, sending out questionnaires and reminders on their behalf. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Oxford Knee Score (OKS) questionnaire 1 year after randomisation |
| Secondary outcome measures | Patient reported questionnaires at 3 months, 6 months and 1 year post randomisation: 1. Oxford Knee Score 2. Knee Injury & Osteoarthritis Outcome Score 3. EQ-5D-5L Quality of health questionnaire Resource data will be collected at 3 months, 6 months and 1 year post randomisation, specifically: 4. Postoperative complications 5. Need for further surgery 6. Further patella resurfacing surgery 7. Resource use and costs within 1 year 8. Mortality data |
| Overall study start date | 01/04/2022 |
| Overall study end date | 31/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 530; UK Sample Size: 530 |
| Participant inclusion criteria | 1. 18 years of age or older 2. Elective primary Total Knee Replacement (TKR) for primary Osteoarthritis (OA) 3. Resident of England (English postcode) and surgery in an NHS England hospital |
| Participant exclusion criteria | 1. Revision TKR 2. Unicompartmental knee replacement 3. Primary TKR with: 3.1. need for constrained implants (e.g., constrained condylar or hinge), 3.2. isolated patellofemoral OA, 3.3. history of septic arthritis, 3.4. diagnosis other than primary OA 4. Intra-operative patellar thickness insufficient for safe patellar resurfacing as determined by the treating surgeon (patellar thickness will be recorded in the case report forms for monitoring purposes) 5. Patient unable/unwilling to adhere to trial procedures 6. Patient unable to provide written informed consent. 7. Participating in another study that may affect the outcomes of this trial or that does not permit co-enrolment in another study or where co-enrolment would be burdensome to the patient. This will be assessed on a case-by-case basis by the local PI, in consultation with the co-CIs. |
| Recruitment start date | 17/04/2023 |
| Recruitment end date | 01/10/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Luton
LU4 0DZ
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Taunton
TA1 5DA
United Kingdom
Liverpool
L7 8XP
United Kingdom
Truro
TR1 3LJ
United Kingdom
Coventry
CV2 2DX
United Kingdom
Dartford
DA2 8DA
United Kingdom
Salisbury
SP2 8BJ
United Kingdom
York
YO31 8HE
United Kingdom
London
SE13 6LH
United Kingdom
Sponsor information
Hospital/treatment centre
Southmead Hospital
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 117 4149330 |
|---|---|
| researchsponsor@nbt.nhs.uk | |
| Website | http://www.nbt.nhs.uk/ |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/10/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 08/02/2023 | 24/02/2023 | No | Yes |
| Protocol file | version 2.0 | 08/02/2023 | 24/02/2023 | No | No |
| HRA research summary | 26/07/2023 | No | No | ||
| Protocol article | 03/06/2024 | 04/06/2024 | Yes | No |
Additional files
Editorial Notes
04/06/2024: Publication reference added.
14/05/2024: The following changes were made:
1. Nottingham University Hospitals NHS Trust and Yeovil District Hospital NHS Foundation Trust were removed; and, Musgrove Park Hospital, Royal Liverpool University Hospital, Royal Cornwall Hospital, Walsgrave General Hospital, Darent Valley Hospital, Salisbury District Hospital, York Hospital, and University Hospital Lewisham were added as study participating centres.
2. A study contact was updated.
04/04/2023: The recruitment start date was changed from 01/04/2023 to 17/04/2023.
01/03/2023: Internal review.
13/02/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
