KORAL

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)

KORAL

Click here for further details on this project

Publications

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).