The primary aim of this study is to evaluate the clinical effectiveness of prefabricated foot orthoses versus flat shoe inserts in the treatment of pain associated with patellofemoral osteoarthritis (kneecap arthritis). This study is a multicentre, randomised, participant-and-assessor blinded trial with two parallel groups, a 3 month observation period (pre-randomisation) and 12 month follow-up. 160 participants will be randomised to one of two groups (prefabricated foot orthoses or flat shoe inserts). Primary and secondary outcome measures will be collected during the observation period, baseline, and at 3, 6, 9 and 12 months. The primary outcome will be worst knee pain severity during a self-nominated aggravating activity in the previous week measured on a 100 mm visual analogue scale. Secondary outcomes include global rating of change, symptoms, function, health-related quality of life, kinesiophobia, use of co-interventions for knee pain, as well as economic analyses.

Staff: Dr Natalie J Collins, Jade M Tan, Prof Hylton B Menz, Dr Trevor G Russell, Prof Anne J Smith, Prof Bill Vicenzino, A/Prof Shannon E Munteanu, Prof Rana S Hinman, Dr Terry P Haines, Dr Harvi F Hart, Brooke E Patterson, Gearoid Cleary, Joel W Donnar, Dr Liam R Maclachlan, Prof Kay M Crossley

Study protocol: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371962