A Multi-center, Randomized, Double-blind, Active-controlled, Non-inferiority, Pivotal Clinical Study to Evaluate the Safety and Efficacy of Intra-articular Filler 'ALLOHEAL' in Knee Osteoarthritis Patients
ENDOVISION Co., Ltd. has developed an intra-articular knee injection with sodium polynucleotide, chitosan, and type I collagen as its main components, and aims to demonstrate the non-inferiority of the investigational device, ALLOHEAL, compared with the control device, Conjuran®, when administered intra-articularly to patients with knee osteoarthritis for the purpose of reducing mechanical friction within the joint cavity.
• 1)Men and women aged ≥40 and \<80 years at the date of signing the written informed consent.
⁃ Diagnosed with knee osteoarthritis according to the American College of Rheumatology (ACR) guidelines within 24 weeks prior to the screening visit or at the screening visit.
⁃ Experiencing pain in the osteoarthritic knee for at least 8 weeks. 4)At the screening visit, having a Kellgren-Lawrence grade I-III severity in the knee joint selected for evaluation based on X-ray findings (if both knees are symptomatic and show the same weight-bearing VAS score, the knee with the higher Kellgren-Lawrence grade will be selected as the target knee; the target knee cannot be changed during the clinical trial).
⁃ At the screening visit, having a weight-bearing VAS (Visual Analogue Scale) score of at least 40 mm in at least one knee joint (if both knees are symptomatic, the knee with the higher weight-bearing VAS score will be selected as the target knee; the target knee cannot be changed during the clinical trial).
⁃ At the screening visit, having a Body Mass Index (BMI) of less than 35 kg/m². 7)Able to walk without assistive devices such as a walker or cane (however, if the subject has been clinically using an assistive device for ≥24 weeks prior to the screening visit, assessment can be conducted including the device, and the same device must continue to be used until the completion of the trial).
⁃ Willing to voluntarily sign the written informed consent form. 9)Capable of understanding and complying with the procedures and visit schedule of the clinical trial.