Dasa Vinod, Mihalko William, Rivadeneyra Adam, Urban Joshua, Wickline Andrew, Rogenmoser David, Concoff Andrew, Spitzer Andrew, Mont Michael A
Louisiana State University Health Services Center, 2021 Perdido Avenue, New Orleans, LA, USA.
University of Tennessee Health Science Center, Campbell Clinic Orthopaedics, Memphis, TN, USA.
Ther Adv Musculoskelet Dis. 2024 Dec 16;16:1759720X241304193. doi: 10.1177/1759720X241304193. eCollection 2024.
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.
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.
The IGOR is a prospective, observational, longitudinal, multicenter registry (NCT05495334) examining knee OA pain treatment outcomes at intervals up to 18 months after treatment.
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.
Ethical approval was granted by Advarra, Inc. (protocol number, Pro00050981).
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.
Clinicaltrials.gov, NCT05495334.
骨关节炎（OA）是美国成年人残疾的主要原因，最常影响膝关节。膝关节OA治疗指南包括行为、非药物、药物和手术干预措施。虽然新兴的膝关节OA治疗方法在疼痛控制方面显示出前景，但在治疗的疗效、安全性、比较有效性和实际价值方面仍存在数据空白。
膝关节结局创新注册研究（IGOR）正在前瞻性收集真实世界数据，以评估膝关节OA治疗的临床有效性、安全性、健康相关生活质量和医疗资源利用情况。
IGOR是一项前瞻性、观察性、纵向、多中心注册研究（NCT05495334），在治疗后长达18个月的时间间隔内检查膝关节OA疼痛治疗结局。
所有临床管理决策均通过医生与患者共同参与的共同决策过程做出。针对指标关节的治疗可能包括各种关节内注射、口服阿片类和非阿片类药物（包括非甾体抗炎药）、冷冻神经阻滞、射频消融、新型治疗方式、其他物理治疗方式（包括肌肉强化）以及全膝关节置换术。记录患者报告的评估结果以及医生提供的病历数据。对每个研究点进行定期数据质量评估，并有外部监测人员确保数据质量和完整性。一个指导委员会确保透明度，并监督行政、法律、伦理和科学决策。比较不同治疗方法内部和之间的治疗结局。
已获得Advarra公司的伦理批准（方案编号，Pro00050981）。
IGOR注册研究的数据将进一步阐明膝关节OA治疗单独或联合使用时的有效性、安全性和实际价值。真实世界治疗模式的特征将有助于更好地理解特定治疗的影响。
Clinicaltrials.gov，NCT05495334。
