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Tests treatment safety and results for Knee Osteoarthritis
Official title A Comparative Study on the Safety and Efficacy of the Intra-Articular Injectable Filler ALLOHEAL in Patients With Knee Osteoarthritis
ClinicalTrials.gov ID: NCT07513415
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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...
- 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...
- 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...
- 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...
You likely can't join if
- 1)History of surgical procedures (including meniscectomy or arthroscopic surgery) on the target knee within 24 weeks prior to the screening visit...
- 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)...
See the full eligibility 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...
- 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...
- 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...
- 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Uijeongbu-si, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Uijeongbu-si, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.