Innovations in Genicular Outcomes Registry (IGOR): protocol for a real-world registry study of treatments for knee osteoarthritis
Abstract
BACKGROUND: Osteoarthritis (OA) is the leading cause of disability among US adults and most commonly affects the knee. Guidelines for knee OA treatment include behavioral, nonpharmacological, pharmacological, and surgical interventions. While emerging knee OA treatments show promise for pain control, data gaps remain regarding the efficacy, safety, comparative effectiveness, and real-world value of treatments. OBJECTIVES: The Innovations in Genicular Outcomes Registry (IGOR) is prospectively collecting real-world data to assess clinical effectiveness, safety, health-related quality of life, and healthcare resource utilization of knee OA treatments. DESIGN: The IGOR is a prospective, observational, longitudinal, multicenter registry (NCT05495334) examining knee OA pain treatment outcomes at intervals up to 18 months after treatment. METHODS AND ANALYSIS: All clinical management decisions are made via shared decision-making involving both the physician and the patient. Index joint-directed treatments may include various intra-articular injections, oral opioid and nonopioid medications (including nonsteroidal anti-inflammatory drugs), cryo nerve blocks, radiofrequency ablations, novel treatment modalities, other physical therapy modalities (including muscle strengthening), and total knee arthroplasties. Patient-reported assessments along with physician-provided medical record data are recorded. Regular data quality assessments are conducted for each site, and an outside monitor ensures data quality and integrity. A steering committee ensures transparency and oversees administrative, legal, ethical, and scientific decisions. Treatment outcomes within and between therapies are compared. ETHICS: Ethical approval was granted by Advarra, Inc. (protocol number, Pro00050981). DISCUSSION: Data from the IGOR registry study will further elucidate the effectiveness, safety, and real-world value of knee OA treatments individually or in combination. Characterization of real-world treatment patterns will help better understand the impact of specific treatments. TRIAL REGISTRATION: Clinicaltrials.gov, NCT05495334.