Condition category
Musculoskeletal Diseases
Date applied
08/04/2009
Date assigned
09/04/2009
Last edited
04/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
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 October 2016

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Dr David Beard
david.beard@ndorms.ox.ac.uk

Trial website

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

Contact information

Type

Scientific

Primary contact

Dr David Beard

ORCID ID

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

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
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0020/52409/PRO-08-14-08.pdf

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 below 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

31/10/2016

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

01/11/2009

Recruitment end date

31/10/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

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

04/03/2016: Plain English summary added. On 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.