The effectiveness and cost-effectiveness of arthroscopic lavage in the treatment of early osteoarthritis of the knee (KORAL)
A feasibility study was conducted to elicit whether it was safe, acceptable to surgeons, anaesthetists and patients to use a sham procedure in a trial. If a sham procedure was acceptable then it would be incorporated into a trial that also included an economic evaluation. The sham procedure was felt necessary as arthroscopic lavage may be accompanied by a substantial placebo effect.
The feasibility study showed that it was safe and acceptable to conduct a trial that included placebo surgery.
Outcome and Translation
The results helped to inform other research where the inclusion of a sham (placebo) surgery might be considered. Although placebo surgery was acceptable, a full trial did not commence as the use of arthroscopic lavage was declining and the substantial cost of the trial (≈ £900,000) was felt to be no longer justified.
HERU researchers involved in this research project: Luke Vale (HERU/HSRU)
External Collaborators: M Campbell, V Entwistle, A Grant, K McCormack, J Norrie, C Ramsay (HSRU, University of Aberdeen); B Cuthbertson (Sunnybrook Health Science Centre, Toronto); R Carlson (University of Edinburgh); A Donaldson (Arthritis Care Scotland); R Fitzpatrick, A Gray, D Murray (University of Oxford); J Hutchison, A Sutherland (Division of Applied Health Sciences, University of Aberdeen); M Johnston (Department of Psychology, University of Aberdeen) and D Rowley (University of Dundee)
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Campbell, M.K., Skea, Z.C., Sutherland, A.G., Cuthbertson, B.H., Entwistle, V.A., McDonald, A.M., Norrie, J.D., Carlson, R.V., Bridgman, S. and Koral Study Group (2010) 'Effectiveness and cost-effectiveness of arthroscopic lavage in the treatment of osteoarthritis of the knee: a mixed methods study of the feasibility of conducting a surgical placebo-controlled trial (the KORAL study)', Health Technology Assessment, 14(5).