Recommendations for the conduct of efficacy trials of treatment devices in osteoarthritis: A report from a working group of the Arthritis Research UK Osteoarthritis and Crystal Disorders Clinical Study Group

Objective: There are unique challenges to designing and carrying out high quality trials testing therapeutic devices in osteoarthritis and other rheumatic diseases. Such challenges include determining the mechanisms of action of the device and the appropriate sham. Design of device trials is more challenging than that of placebo-controlled drug trials. This study reports recommendations for designing device trials.

Methods: An Arthritis Research UK study group comprised of 30 persons including rheumatologists, physiotherapists, podiatrists, engineers, orthopedists, trialists and patients, including many who have carried out device trials, met and using a Delphi-styled approach, came to consensus on recommendations for device trials.

Results: Challenges unique to device trials include defining the mechanism of action of the device and therefore, the appropriate sham which provides a placebo effect without duplicating the action of the active device. Should there be no clear-cut mechanism of action, a three-arm trial including a ‘no treatment’ arm and one with presumed sham action was recommended. For individualised devices, generalisable indications and standardisation of the devices are needed so that treatments can be generalised.

Conclusion: A consensus set of recommendations for device trials was developed, providing a basis for improved trial design, and hopefully improvement in the number of effective therapeutic devices for rheumatic diseases.