Condition category
Musculoskeletal Diseases
Date applied
08/04/2009
Date assigned
09/04/2009
Last edited
10/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

https://viis.abdn.ac.uk/HSRU/topkat/

Contact information

Type

Scientific

Primary contact

Prof David Beard

ORCID ID

http://orcid.org/0000-0001-7884-6389

Contact details

Nuffield Department of Orthopaedic
Rheumatology & Musculoskeletal Sciences
Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom
+44 (0)1865 227695
david.beard@ndorms.ox.ac.uk

Type

Scientific

Additional contact

Ms Loretta Davies

ORCID ID

Contact details

Surgical Intervention Trials Unit
NDORMS
Botnar Research Centre
University of Oxford
Nuffield Orthopaedic Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
+44 (0)1865 737210
loretta.davies@ndorms.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01352247

Protocol/serial number

HTA 08/14/08; Version 1

Study information

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

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

Oxfordshire REC C, 04/09/2009, ref: 09/H606/88

Study design

Multicentre prospective superiority randomised controlled 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 to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/11/2009

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

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

United Kingdom

Trial participating centre

Nuffield Department of Orthopaedic, Rheumatology & Musculoskeletal Sciences
Oxford
OX3 7LD
United Kingdom

Trial participating centre

Royal Gwent Hospital
Aneurin Bevan University Health Board Cardiff Road
Newport
NP20 2UB
United Kingdom

Trial participating centre

Musgrave Park Hospital
Belfast Health and Social Care Trust Stockman's Lane
Belfast
BT9 7JB
United Kingdom

Trial participating centre

Chesterfield Royal Hospital
Chesterfield Royal Hospital NHS Foundation Trust Calow
Chesterfield
S44 5BL
United Kingdom

Trial participating centre

University Hospital of North Durham
County Durham and Darlington NHS Foundation Trust North Road
Durham
DH1 5TW
United Kingdom

Trial participating centre

Royal Blackburn Teaching Hospital
East Lancashire Hospitals NHS Trust Haslingden Road
Blackburn
BB2 3HH
United Kingdom

Trial participating centre

Great Western Hospital
Great Western Hospitals NHS Foundation Trust Marlborough Road
Swindon
SN3 6BB
United Kingdom

Trial participating centre

Harrogate District Hospital
Harrogate and District NHS Foundation Trust Lancaster Park Rd
Harrogate
HG2 7SX
United Kingdom

Trial participating centre

Hull Royal Infirmary
Hull and East Yorkshire Hospitals NHS Trust Anlaby Road
Hull
HU3 2JZ
United Kingdom

Trial participating centre

Medway Maritime Hospital
Maidstone and Tunbridge Wells NHS Trust Windmill Road
Gillingham
ME7 5NY
United Kingdom

Trial participating centre

Pinderfields Hospital
Mid Yorkshire Hospitals NHS Trust Aberford Road
Wakefield
WF1 4DG
United Kingdom

Trial participating centre

Milton Keynes University Hospital
Milton Keynes University Hospital NHS Foundation Trust Standing Way Eaglestone
Milton Keynes
MK6 5LD
United Kingdom

Trial participating centre

Woodend Hospital
NHS Grampian Eday Road
Aberdeen
AB15 6XS
United Kingdom

Trial participating centre

Southmead Hospital Bristol
North Bristol NHS Trust Southmead Road Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

The Cumberland Infirmary
North Cumbria University Hospitals NHS Trust Newtown Road
Carlisle
CA2 7HY
United Kingdom

Trial participating centre

University Hospital of North Tees
North Tees and Hartlepool NHS Foundation Trust Hardwick
Stockton on Tees
TS19 8PE
United Kingdom

Trial participating centre

Royal United Hospitals Bath
NHS Foundation Trust Combe Park
Bath
BA1 3NG
United Kingdom

Trial participating centre

King’s Mill Hospital
Sherwood Forest Hospitals NHS Foundation Trust Mansfield Road
Sutton-in-Ashfield
NG17 4JL
United Kingdom

Trial participating centre

Torbay Hospital
South Devon Healthcare NHS Foundation Trust Lowes Bridge
Torquay
TQ2 7AA
United Kingdom

Trial participating centre

Stepping Hill Hospital
Stockport NHS Foundation Trust Poplar Grove Hazel Grove
Stockport
SK2 7JE
United Kingdom

Trial participating centre

Hillingdon Hospitals
The Hillingdon Hospitals NHS Trust Pield Heath Road
Uxbridge
UB8 3NN
United Kingdom

Trial participating centre

Ipswich Hospital
Ipswich Hospital NHS Trust Heath Road
Ipswich
IP4 5PD
United Kingdom

Trial participating centre

Leicester General Hospital
University Hospitals of Leicester NHS Trust Gwendolen House Gwendolen Road
Leicester
LE5 4QF
United Kingdom

Trial participating centre

Royal Stoke University Hospital
University Hospitals of North Midlands NHS Trust Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

Trial participating centre

Southampton General Hospital
University Hospital Southampton NHS Foundation Trust Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Lincoln County Hospital
United Lincolnshire Hospitals NHS Trust Greetwell Road
Lincoln
LN2 5QY
United Kingdom

Trial participating centre

Pilgrim Hospital Boston
United Lincolnshire Hospitals NHS Trust Sibsey Road
Boston
PE21 9QS
United Kingdom

Trial participating centre

Yeovil District Hospital
Yeovil District Hospital NHS Foundation Trust Higher Kingston
Yeovil
BA21 4AT
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Clinical Trials and Research Governance Unit
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
United Kingdom
+44 (0)1865 743002
heather.house@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.admin.ox.ac.uk/rso/clinical

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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 statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24028414

Publication citations

  1. Protocol

    Beard D, Price A, Cook J, Fitzpatrick R, Carr A, Campbell M, Doll H, Campbell H, Arden N, Cooper C, Davies L, Murray D, Total or Partial Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial., Trials, 2013, 14, 292, doi: 10.1186/1745-6215-14-292.

Additional files

Editorial Notes

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.