The Natural History of Knee Osteoarthritis: India-based Knee Osteoarthritis Evaluation (iKare): A Study Protocol
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METHODOLOGY: Multi-center, cross-sectional, observational study. STUDY CENTER(S): Multiple centers in India. NUMBER OF PARTICIPANTS: 1,000. PRIMARY RESEARCH OBJECTIVE: To characterize patients and treatment utilized for orthopedic patients presenting to both private and public hospital centers in India with knee pain and symptoms suggestive of knee arthritis. INCLUSION CRITERIA: All patients 18 years of age or older who present to a recruiting hospital for treatment of knee pain will be eligible for participation. The subjects must be able to understand and complete the questionnaire. EXCLUSION CRITERIA: Patients with total knee replacement, open wound or evidence of recent surgery, or with a current or a history of tumor and/or fracture in the tibial plateau, femoral condyle or patella, in the affected knee are not eligible. STUDY OUTCOMES: This study aims to characterize the following: general demographics of patients presenting with knee pain, severity of knee symptoms at time of presentation, severity of knee pathology at time of presentation, factors associated with the decision to seek medical care, previous treatments and health care contacts, planned treatment, and gaps in treatment perceived by the patient and treating surgeons.
