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| [ Print-friendly version ] |
| A randomised controlled trial of different knee prostheses |
| ISRCTN | ISRCTN45837371 |
| ClinicalTrials.gov identifier | |
| Public title | A randomised controlled trial of different knee prostheses |
| Scientific title | |
| Acronym | KAT (Knee Arthroplasty Trial) |
| Serial number at source | HTA 95/10/01 |
| Study hypothesis |
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 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. Details of this study can also be found at: 1. http://www.hta.ac.uk/1065 2. http://www.charttrials.abdn.ac.uk/trials.shtml#KAT Protocol available in http://www.ncchta.org/protocols/199500100001.pdf Please note that an incorrect target number of participants was entered in this ISRCTN record at time of registration. Therefore, the number (413 participants) has been amended to the correct number (approximately 2,450) as of 27/02/2009. |
| Ethics approval | Multi-centre Research Ethics Committee for Scotland, approved on 30/11/1998 (ref: MREC/98/0/100) |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Primary knee replacement surgery |
| Participants - inclusion criteria |
Added as of 23/01/2009:
1. A decision has been made to have primary knee replacement surgery 2. The surgeon has no clear preference for a specific option in at least one of the comparisons 3. Both males ane females, no age limits |
| Participants - exclusion criteria | Does not meet inclusion criteria |
| Anticipated start date | 31/12/1998 |
| Anticipated end date | 31/12/2010 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 2,450 |
| Interventions |
Current interventions as of 23/01/2009:
The trial is evaluating four aspects of knee replacements: 1. Metal backing of the tibial component comapred with a single high density polyethylene component (350 participants) 2. Patellar resurfacing compared with no resurfacing (1400 participants) 3. A polyethylene mobile bearing component between the tibia and femur compared with a fixed bearing arthroplasty (350 participants) 4. Uni-compartmental arthroplasty compared with toal knee replacement (350 participants) Individual patients can participate in a maximum of two comparisons and then only if the surgeon responsible for care is substantially uncertain about these particular aspects. Previous interventions: The four management options are: 1. Metal versus non-metal backing of the tibial component 2. Whether to resurface the patella 3. Unicompartmental versus total knee arthroplasty 4. Mobile versus fixed bearing |
| Primary outcome measure(s) |
Current primary outcome measures as of 23/01/2009:
Oxford Knee Score (postal questionnaire) at 3 months and then annually thereafter. Previous primary outcome measures: Outcomes will be in terms of complications and patient-assessed pain and function, principally conducted by post. Costings include those relating to 1. Early complications expected immediately post operatively from medical effects 2. Medium-term complications such as dislocation and infection 3. Late complications of wear, loosening and infection. |
| Secondary outcome measure(s) |
Added as of 23/01/2009:
Complications and patient-assessed pain and function, assessed principally by postal questionnaires including: 1. SF-12 2. EQ-5D 3. Questions about any further hospital admissions and surgery 4. Costings: 4.1. Early complications expected immediately post-operatively from medical effects 4.2. Medium-term complications such as dislocation and infection 4.3. Late complications of wear, loosening and infection Questionnaires are completed at 3 months and then annually thereafter. |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19122088 |
| Contact name | Prof David Murray |
| Address |
Nuffield Orthopaedic Centre
University of Oxford Windmill Road Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 7LD |
| Country | United Kingdom |
| Tel | +44 (0)1865 227457 |
| Fax | +44 (0)1865 227671 |
| david.murray@ndos.ox.ac.uk | |
| Sponsor | Department of Health (UK) |
| Address |
Quarry House
Quarry Hill |
| City/town | Leeds |
| Zip/Postcode | LS2 7UE |
| Country | United Kingdom |
| Sheila.Greener@doh.gsi.gov.uk | |
| Sponsor website: | http://www.dh.gov.uk/en/index.htm |
| Date applied | 25/04/2003 |
| Last edited | 04/03/2009 |
| Date ISRCTN assigned | 25/04/2003 |
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