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ISRCTN
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ISRCTN02328576
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ClinicalTrials.gov identifier
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Public title
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The effectiveness and cost-effectiveness of arthroscopic lavage in the treatment of osteoarthritis of the knee
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Scientific title
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Acronym
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KORAL
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Serial number at source
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HTA 03/48/01
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Study hypothesis
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This is a pilot study, the design of which has been informed by extensive qualitative feasibility work, to assess in two UK centres (Aberdeen and North Staffordshire) the feasibility of mounting a multicentre, placebo-controlled trial to evaluate the effectiveness of arthoscopic lavage for osteoarthritis of the knee.
Please note that, as of 11/05/2009, the anticipated end date has been updated from 30/06/2010 to 31/10/2008.
Protocol V2 dated July 2006 is available on http://www.hta.ac.uk/protocols/200300480001.pdf
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Lay summary
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Not provided at time of registration
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Ethics approval
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Application submitted to MREC, Scotland as of 09/06/06
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Study design
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Pilot, randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Osteoarthritis of the knee
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Participants - inclusion criteria
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1. Adults (18 years or older) with radiological evidence of osteoarthritis (OA) of the knee who might routinely be considered for arthroscopic lavage
2. Fit for general anaesthetic (American Society of Anesthesiologists [ASA] grade 1 and 2)
3. Able to give informed consent
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Participants - exclusion criteria
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1. Patients for whom the orthopaedic surgeon judges that arthroscopic lavage is clearly indicated
2. Patients for whom arthroplasty is clearly indicated
3. Clear contraindication to general anaesthesia
4. Inability to fill in follow-up questionnaires
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Anticipated start date
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01/07/2005
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Anticipated end date
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31/10/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Approximately 70
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Interventions
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1. Arthroscopic lavage (+/- debridement as deemed clinically necessary)
2. Placebo arthroscopic lavage
3. Non-operative management with specialist re-assessment
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Primary outcome measure(s)
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1. To examine whether the trial processes as currently planned are appropriate, feasible and acceptable to patients, clinicians and the trial office staff
2. To quantify the throughput of eligible patients
3. To quantify the number of patients approached and the proportion of patients who would accept randomisation to the trial
4. To examine the acceptability of the trial information material to patients
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Secondary outcome measure(s)
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The secondary research outcomes of the main trial (in which we anticipate the pilot patients' data being included) are:
1. General quality of life as measured by 12-item short form questionnaire (SF-12)
2. Patient utility as measured by EQ5D
3. Non-steroidal anti-inflammatory drug (NSAID) or analgesic use
4. Use of other treatments outside the trial interventions
5. Use and cost of health services
6. Cost-effectiveness - incremental cost per quality adjusted life year gained
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://www.charttrials.abdn.ac.uk/
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Publications
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1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21338481
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Contact name
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Prof
Marion
Campbell
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Address
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Health Services Research Unit
University of Aberdeen
Foresterhill
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City/town
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Aberdeen
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Zip/Postcode
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AB25 2ZD
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Country
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United Kingdom
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Tel
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+44 (0)1224 554480
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Fax
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+44 (0)1224 554580
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Email
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m.k.campbell@abdn.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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08/06/2006
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Last edited
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11/07/2011
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Date ISRCTN assigned
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09/06/2006
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