Actively Recruiting
A Comparative Study on the Safety and Efficacy of the Intra-Articular Injectable Filler ALLOHEAL in Patients With Knee Osteoarthritis
Led by Endovision Co., Ltd. · Updated on 2026-04-07
286
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
Sponsors
E
Endovision Co., Ltd.
Lead Sponsor
T
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Comparative Study on the Safety and Efficacy of the Intra-Articular Injectable Filler ALLOHEAL in Patients With Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 40 to less than 80 years at the time of consent
- Diagnosed with knee osteoarthritis per American College of Rheumatology guidelines within 24 weeks before or at screening
- Pain in the osteoarthritic knee for at least 8 weeks
- Kellgren-Lawrence grade I-III severity in the target knee based on X-ray at screening
- Weight-bearing Visual Analog Scale score of at least 40 mm in the target knee at screening
- Body Mass Index (BMI) below 35 kg/m² at screening
- Able to walk without assistive devices or have used the same device consistently for at least 24 weeks prior
- Willing to sign informed consent
- Able to understand and follow study procedures and visit schedule
You will not qualify if you...
- History of surgery or arthroscopic treatment on the target knee within 24 weeks before screening
- Need for surgical intervention on the target knee at screening
- Ligament instability grade II or higher in the target knee at screening
- Orthopedic issues like fractures or joint deformities affecting the target knee
- Pain from other joint problems or osteoarthritis in different areas that affect knee pain assessment
- Certain comorbidities including rheumatoid arthritis, gout, severe liver, heart, or kidney disease, recent malignancy, and coagulation disorders
- Infection, inflammation, or severe fluid buildup in the target knee
- Local skin disorders at the target knee
- Hypersensitivity to porcine-derived products or components of the investigational device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seok Jung Kim
Uijeongbu-si, South Korea
Actively Recruiting
Research Team
K
Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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