Details of HTA project in progress
Last updated: 31 August 2010 - Next update due: 7 September 2010
Research type: |
Primary Research (e.g. trial) |
Project title: |
A randomised controlled trial of different knee prostheses |
 Outputs in journals arising from this project
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Project ref: |
95/10/01 |
Cost: |
£1,381,371 |
Chief Investigator : |
Professor David Murray, Professor in Orthopaedics, Nuffield Department of Orthopaedic Surgery, University of Oxford |
Start Date: |
December 1998 |
Estimated date of publication in HTA journal series: |
Late 2012. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
Knee replacement surgery is an extremely successful treatment for arthritis and other knee problems. There are, however, many unanswered questions about which type of knee replacement is best under which circumstances. Aims The KAT study aims to address four main questions about knee replacement surgery: 1) Should the inner surface of the knee cap be resurfaced? Some surgeons routinely replace the inner surface of the knee cap while others virtually never do. This study will provide information as to whether it is necessary to replace the inner surface of the knee cap at the time of knee replacement 2) Should the tibial component have a metal back? A knee replacement consists of two parts: the part used to resurface the thigh bone (the femoral component); and, the part used to resurface the shin bone (the tibial component). The tibial component can be made completely of plastic or can be partly metal and partly plastic. This study will explore whether the metal back is an advantage or not. 3) Should the knee replacement have a mobile bearing? Many manufacturers have introduced knee replacements with 'mobile bearings'. In these, the plastic of the tibial part is free to move on a flat surface of metal of the tibial component. This should allow more normal movement of the knee, but there is a chance that the bearing may dislocate and come out of joint. This study will find out the benefits and any problems of mobile bearings. 4) Should a unicompartmental or total knee replacement be performed? The joint between the thigh bone and the shin bone consists of two parts: the inside of the knee (the medial compartment) and the outside of the knee (the lateral compartment). In some circumstances it is possible to replace only the damaged compartment (unicompartmental knee replacement). The alternative is total knee replacement where the whole knee is replaced. By comparing both approaches we will be able to find out when it is best to use a unicompartmental knee replacement. Methodology The KAT study is a multicentre randomised controlled trial. The trial has a 'partial factorial design' where participants can be invited to take part in one or two of the study comparisons depending on the extent and type of disease in the knee. Planned outcomes At three months and annually after the operation patients are asked (by postal questionnaire) about their knee function and general quality of life. Information on short-term complications of surgery and long-term recovery are also collected. |
Project Abstract: |
A UK wide network of clinical centres will be established to conduct randomised partial factorial trials on current practice of knee replacement. Independent management by health services research units is a feature of the application. Individual surgeons will be invited to consider areas of uncertainty concerning current knee prosthetic and participate in randomisation between certain design aspects of knee replacement systems which are otherwise similar in all other respects. The four management options are (i) metal versus non-metal backing of the tibial component (ii) whether to resurface the patella (iii) unicompartmental versus total knee arthroplasty (iv) mobile versus fixed bearing. Costings include those relating to (i) early complications expected immediately post operatively from medical effects and (ii) medium-term complications such as dislocation and infection, and (iii) late complications of wear, loosening and infection. The project will require two phases, each of six years. At end of first phase, the trial will demonstrate short to medium-term variations in costs and outcome relating to the four management options. The second phase is necessary in order to demonstrate prosthesis design-related adverse events. This trial will produce authoritative data to inform purchasers, providers, consumers and clinicians about this very commonly performed procedure in the NHS. |
MeSH* index primary terms: |
ARTHROPLASTY-REPLACEMENT-KNEE Q-methods; KNEE-PROSTHESIS |
MeSH* index secondary terms: |
RANDOMIZED-CONTROLLED-TRIAL; CLINICAL-TRIAL; MULTICENTER-STUDY; PROSTHESIS-DESIGN; POSTOPERATIVE-COMPLICATIONS; PROSTHESIS-FAILURE; HUMAN |
NRR* number, if applicable: |
N0484008637 (*National Research Register). The National Research Register was a public database of ongoing and recently completed research projects funded by, or of interest to, the United Kingdom's National Health Service (NHS). It is now an archive of projects from early 2000 to September 2007. Search the NRR archive. |
ISRCTN* number: | ISRCTN 45837371 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN45837371 |
Project Protocol: |
Project protocol (pdf format, 198 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1065 |
Outputs from this project
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