Effects of a novel foot–ankle orthosis in the non-operative treatment of unicompartmental knee osteoarthritis

INTRODUCTION: Unloader braces are non-surgical treatment options for patients with unicompartmental knee osteoarthritis (OA). However, many patients do not adhere to brace treatment because of complications related to discomfort and poor fit. An alternative to knee bracing is an ankle–foot orthosis (AFO) with a lever arm that presses the lower leg into valgus or varus. The aim of this study is to evaluate the clinical benefits of this AFO for patients with unicompartmental knee OA. MATERIALS AND METHODS: Twenty-three patients with knee OA were enrolled in this observational study. The primary clinical outcome measure was the Western Ontario and McMasters Universities Arthritis Index (WOMAC) total score. Secondary outcome measures included WOMAC subscores, visual analogue pain scale, activity restriction and complication rate. Clinical scores were collected at start and 3, 6, 9, and 12 months after enrollment. Statistical evaluation was performed using the Student’s t test. RESULTS: Of the patients enrolled, 83 % suffered from medial compartment OA. Most patients had Grade II OA according to the Kellgren and Lawrence classification. WOMAC total score, both subscores and visual analogue pain scale were significantly improved over time. Patients also noted a reduction in restrictions to activities of daily living and sport-related activities while using the AFO. No patients discontinued orthosis use because of adverse effects. Two types of complications were noted: discomfort or light pressure sores around the ankle (7 patients), and wear and tear of the shoe in which the AFO was worn (14 patients). CONCLUSIONS: This observational study suggests that this AFO is effective at significantly reducing pain and stiffness as well as improving the physical function of patients with mild to moderate unicompartmental osteoarthritis of the knee.