New concept of orthosis treatment for knee osteoarthritis: Clinical and radiological outcomes

BACKGROUND: Given the increasing numbers of young patients with knee osteoarthritis there is a need for treatments that can postpone a joint prosthesis (total knee replacement). OBJECTIVE: As an alternative to the effective yet invasive knee joint distraction procedure, a knee orthosis was developed aiming to unload the affected knee and improving synovial fluid flow. The aim of this study was to examine the effectiveness of using a load-reducing orthosis for two months on functioning, pain, and disease progression (e.g. amount of damaged cartilage) in patients with symptomatic osteoarthritis of the knee for at least one year. METHODS: This is an interventional single-center pilot study. Ten patients with symptomatic osteoarthritis of one knee (5 males/5 females; median age 57; age range 42-59) used a custom-made orthosis for 60 days during daily life activities that involved knee loading (e.g. standing, walking, but not during stair climbing). Cycling was not allowed. Clinical outcomes were assessed up to 24 months after intervention at 6 timepoints using patient reported-outcome measures Western Ontario and McMaster Universities Osteoarthritis (WOMAC) range 0-100; Visual Analogue Scale (VAS), range 0-100 for pain. Minimum joint space width (mJSW) was assessed using knee images digital analysis (KIDA) and articular cartilage volume with magnetic resonance imaging (MRI) using custom software at baseline and at 12 and 24 months follow-up. RESULTS: Clinically beneficial effects were found for functioning (WOMAC improvement compared to baseline ranged between 18 points at 3 months follow-up and 31 points at 12 months follow-up, with only the 24-months follow-up (improvement of 27 points) not reaching statistical significance (p < 0.05)) and for pain (VAS improvement compared to baseline at follow-up time points ranged between 41-56 points; all p < 0.05). No improvements in mJSW- or MRI-derived parameters were found. CONCLUSION: This study demonstrates that use of a custom-made knee-unloading orthosis for 60 days can result in improved functional ability and decrease in pain in relatively young patients with knee osteoarthritis. No effect on disease progression could be evidenced.