Total or partial knee arthroplasty trial
| ISRCTN | ISRCTN03013488 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03013488 |
| ClinicalTrials.gov number | NCT01352247 |
| Secondary identifying numbers | HTA 08/14/08; Version 1 |
- Submission date
- 08/04/2009
- Registration date
- 09/04/2009
- Last edited
- 06/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Osteoarthritis is a condition that causes the joints to become painful and stiff. Osteoarthritis of the knee affects a large proportion of the population and this is set to increase over time. Quite often the arthritis is limited to one area of the joint, particularly the inside of the joint. Patients can either have a partial knee replacement or a total knee replacement. The partial knee replacement, as its name suggests, involves the removal and replacement of only the diseased part of the joint. Total knee replacement involves the removal and replacement of the entire knee joint. Total knee replacement is easier to do and considered more reliable (lower failure/revision rate), but it involves cutting away healthy parts of the joint. Partial knee replacement retains healthy tissue and usually achieves better functional results, but is more difficult to do and can have an increased failure/revision rate. There are also significant cost advantages for the healthcare system for partial knee replacements. Unfortunately we currently do not know which type of replacement is best for these particular patients. Hence, the aim of this study is to directly compare the clinical and cost-effectiveness of total knee replacements versus partial knee replacements for patients with osteoarthritis.
Who can participate?
Patients aged 40 or over with osteoarthritis
What does the study involve?
The study is carried out at the local hospital where the patient would normally have their knee replacement. Patients recruited to the study are randomly allocated to undergo either total or partial knee replacement surgery. Patients are then followed up for 10 years after the surgery. The measurements taken to assess which type of knee replacement is better are predominantly patient based. This means that the measurements directly assess how the patient, rather than the surgeon, feels about the outcome after their operation.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
November 2009 to December 2018
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)
Who is the main contact?
Prof. David Beard
david.beard@ndorms.ox.ac.uk
Contact information
Scientific
Nuffield Department of Orthopaedic, Rheumatology & Musculoskeletal Sciences
Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom
 ORCID ID |
0000-0001-7884-6389 |
|---|---|
| Phone | +44 (0)1865 227695 |
| david.beard@ndorms.ox.ac.uk |
Scientific
Surgical Intervention Trials Unit
NDORMS
Botnar Research Centre
University of Oxford
Nuffield Orthopaedic Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
| Phone | +44 (0)1865 737210 |
|---|---|
| loretta.davies@ndorms.ox.ac.uk |
Study information
| Study design | Multicentre prospective superiority randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Clinical and cost-effectiveness of total knee replacements versus partial knee replacements for patients with medial compartment osteoarthritis: a multicentre randomised controlled trial |
| Study acronym | TOPKAT |
| Study hypothesis | To assess the clinical and cost-effectiveness of total knee replacements versus partial knee replacements for patients with medial compartment osteoarthritis. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/081408 |
| Ethics approval(s) | Oxfordshire REC C, 04/09/2009, ref: 09/H606/88 |
| Condition | Osteoarthritis/avascular necrosis |
| Intervention | Total knee replacement surgery versus unicompartmental knee replacement surgery. Patients will be followed up for 10 years post surgery. Going on the average waiting list times of 3 months, the approximate involvement in the study for each participant (recruitment, treatment and follow up) would be 10 years and 3 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Oxford Knee Score: a patient based validated and effective measure of change over time questionnaire. Both the absolute and the change scores will be analysed at 5- and 10-year points post-operation. |
| Secondary outcome measures | 1. American Knee Society Score: to measure the range of motion and function of the knee, measured at 2 months, 1, 5 and 10 years post-surgery 2. UCLA Activity Score: to measure how active the patient is, measured at 2 months, 1, 5 and 10 years post-surgery 3. X-ray to check for immediate problems, assess the outcome of surgery, complications and make long-term predictions, measured at 2 months, 1, 5 and 10 years post-surgery 4. EQ-5D: to provide data for the economic evaluation, measured at 2 months, 1, 2, 3, 4, 5, 7 and 10 years post-surgery 5. Lund Score: to measure patient satisfaction, measured at 2 months, 1, 2, 3, 4, 5, 7 and 10 years post-surgery 6. Other outcomes, e.g., kinematic and gait assessments, measured at 2 months, 1, 5 and 10 years post-surgery |
| Overall study start date | 01/11/2009 |
| Overall study end date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 500 |
| Total final enrolment | 528 |
| Participant inclusion criteria | 1. Medial osteoarthritis with exposed bone on both femur and tibia or avascular necrosis 2. Functionally intact anterior cruciate ligament (superficial damage or splitting is acceptable) 3. Full thickness lateral cartilage 4. Correctable intra-articular varus deformity (suggestive of functionally intact medical cruciate ligament) 5. Medically fit showing an American Society of Anaesthesiologists (ASA) grade 1 or 2 6. Expectancy of over 10 years of active life 7. Aged 40 years or over, either sex |
| Participant exclusion criteria | 1. Require revision knee replacement surgery 2. Have rheumatoid arthritis or other inflammatory disorders 3. Are likely to benefit from a specific prosthesis type 4. Are unlikely to be able to perform required clinical assessment tasks 5. Have symptomatic foot, hip or spinal pathology |
| Recruitment start date | 01/01/2010 |
| Recruitment end date | 30/09/2013 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
OX3 7LD
United Kingdom
Cardiff Road
Newport
NP20 2UB
United Kingdom
Stockman's Lane
Belfast
BT9 7JB
United Kingdom
Calow
Chesterfield
S44 5BL
United Kingdom
North Road
Durham
DH1 5TW
United Kingdom
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
Marlborough Road
Swindon
SN3 6BB
United Kingdom
Lancaster Park Rd
Harrogate
HG2 7SX
United Kingdom
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Windmill Road
Gillingham
ME7 5NY
United Kingdom
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Eday Road
Aberdeen
AB15 6XS
United Kingdom
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Newtown Road
Carlisle
CA2 7HY
United Kingdom
Hardwick
Stockton on Tees
TS19 8PE
United Kingdom
Combe Park
Bath
BA1 3NG
United Kingdom
Mansfield Road
Sutton-in-Ashfield
NG17 4JL
United Kingdom
Lowes Bridge
Torquay
TQ2 7AA
United Kingdom
Poplar Grove
Hazel Grove
Stockport
SK2 7JE
United Kingdom
Pield Heath Road
Uxbridge
UB8 3NN
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Gwendolen House
Gwendolen Road
Leicester
LE5 4QF
United Kingdom
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Greetwell Road
Lincoln
LN2 5QY
United Kingdom
Sibsey Road
Boston
PE21 9QS
United Kingdom
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
Sponsor information
University/education
Clinical Trials and Research Governance Unit
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
England
United Kingdom
| Phone | +44 (0)1865 743002 |
|---|---|
| heather.house@admin.ox.ac.uk | |
| Website | http://www.admin.ox.ac.uk/rso/clinical |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| 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 publications include a final report to the funding body, National Institute for Health Research (NIHR), as well as publications in high-impact peer reviewed journals. The main trial results paper is planned for 2019. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 12/09/2013 | Yes | No | |
| Results article | early results | 01/10/2017 | 13/05/2019 | Yes | No |
| Results article | 5-year results | 31/08/2019 | 22/07/2019 | Yes | No |
| Results article | results | 01/04/2020 | 06/05/2020 | Yes | No |
Editorial Notes
06/05/2020: Publication reference added.
22/07/2019: Publication reference added.
13/05/2019: Publication reference and total final enrolment added.
10/10/2017: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/11/2009 to 01/01/2010.
2. Trial participating centres added.
3. Publication and dissemination plan and IPD sharing statement added.
06/10/2017: The overall trial end date was changed from 31/10/2016 to 31/12/2018.
04/03/2016: Plain English summary added.
17/09/2009: The overall trial start and end dates were changed from 01/06/2009 and 01/06/2023 to 01/11/2009 and 31/10/2016, respectively.
