A Comparative Study on the Safety and Efficacy of the Intra-Articular Injectable Filler ALLOHEAL in Patients With Knee Osteoarthritis

In this clinical trial, based on clinical literature on PN, which is the main component of the investigational device ALLOHEAL, the VAS assessment at Week 16 was set as the primary efficacy endpoint. As the investigational device contains chitosan and collagen in addition to PN, the follow-up period was set to 24 weeks based on the aforementioned literature in order to obtain additional safety data for these two components. Efficacy and safety will be evaluated at 6, 10, 16, and 24 weeks after the initial application of the investigational medical device.

Inclusion criteria

• 1)Men and women aged ≥40 and <80 years at the date of signing the written informed consent.

2)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.

3)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).

5)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).

6)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).

8)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.

Exclusion criteria

• 1)History of surgical procedures (including meniscectomy or arthroscopic surgery) on the target knee within 24 weeks prior to the screening visit. (However, if the subject has a history of joint surgery on the contralateral knee, hip, or other joints that is unlikely to affect the clinical assessment of the target knee, participation in this clinical trial is allowed.) 2)History of arthroscopic treatment on the target knee within 24 weeks prior to the screening visit.

3)Requiring surgical intervention for the target knee at the screening visit. 4)Having ligament instability of grade II or higher in the target knee on physical examination at the screening visit (Grade 0: none, Grade I: 0-5 mm, Grade II: 5-10 mm, Grade III: >10 mm).

5)Presence of orthopedic conditions such as fractures or joint deformities in the target knee that may affect or interfere with treatment efficacy (joint deformity refers to varus or valgus deformity ≥10° in the knee joint).

6)Experiencing pain in the target knee due to surrounding joint structures or coexisting osteoarthritis in other areas (e.g., hip) that may influence assessment of knee pain.

7)Presence of the following comorbidities: Rheumatoid arthritis, spondyloarthritis, connective tissue disease, polymyalgia rheumatica, gout, Paget's disease, septic arthritis, psoriatic arthritis, joint fractures, osteonecrosis, fibromyalgia, chondrocalcinosis

• Amyloidosis
• Severe hepatic, cardiac, or renal disease
• Malignant tumors within the past 5 years
• Coagulation disorders such as hemophilia 8) Infection or inflammation in the target knee joint. 9) Severe effusion in the target knee joint. 10) Local skin disorders at the target knee. 11)Hypersensitivity to porcine-derived products. 12)Hypersensitivity or history of adverse reactions to the main or other components of the investigational medical device used in this clinical trial.