Clinical and economic consequences of the treatment gap in knee osteoarthritis management.

Osteoarthritis affects 27 million American adults of all ages and is a leading cause of disability in middle-aged and older adults. Initial management of knee osteoarthritis symptoms utilizes conservative care although long-term efficacy is poor. Arthroplasty and high tibial osteotomy may be considered for patients with severe pain or disability. We hypothesize that a distinct treatment gap exists for the patient with symptomatic knee osteoarthritis who is unresponsive to conservative care (including simple surgical treatments) yet refuses to undergo or is not an appropriate candidate for more invasive surgical procedures. This treatment gap represents a protracted period in which the patient experiences debilitating pain, reduced quality of life, and a significant financial burden. Approximately 3.6 million Americans linger in the knee osteoarthritis treatment gap and this number will grow to about 5 million people by 2025. The typical knee osteoarthritis treatment gap extends 20 years although the younger osteoarthritis patient is faced with the treatment gap throughout the majority of their adult life. There is great need for a safe, effective, and cost effective treatment option for patients with moderate to severe osteoarthritis that enjoys high patient acceptance.