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Amniotic Suspension Allograft Injection for Knee Osteoarthritis
Sponsor: Chang Gung Memorial Hospital
Summary
There have been few clinical trials on ASA for the treatment of knee osteoarthritis, and there is currently no literature reporting the optimal treatment dosage. Non-surgical treatment options include braces, weight loss, lifestyle changes, oral pain relievers, and intra-articular injections. Recently, placental-derived tissues have gradually been applied in the treatment of knee osteoarthritis. These tissues were initially used primarily for burns, ulcers, and wounds that are difficult to heal, but have now begun to be utilized in the orthopedic field. They have been proven to contain various anti-inflammatory cytokines and growth factors, which can reduce inflammation associated with arthritis. Reducing inflammation not only alleviates the pain of knee osteoarthritis but also improves patients' quality of life. The purpose of this study is to compare the therapeutic effects of amniotic suspension allograft (ASA), hyaluronic acid (HA), and saline on knee osteoarthritis and to examine whether there is a dose-response relationship with ASA injections.
Official title: The Efficacy of Amniotic Suspension Allograft Injection in the Treatment of Knee Osteoarthritis: a Randomized Double-blind Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2024-10-21
Completion Date
2027-12-31
Last Updated
2026-01-26
Healthy Volunteers
No
Conditions
Interventions
ASA injection 40 mg group
Participants will receive intra-articular knee injections under ultrasound guidance with AMNIOGEN® 40mg (HCT Regenerative, New Taipei, Taiwan) diluted in 3.0 mL of sterile normal saline.
ASA injection 20 mg group
Participants will receive intra-articular knee injections under ultrasound guidance with AMNIOGEN® 20mg (HCT Regenerative, New Taipei, Taiwan) diluted in 3.0 mL of sterile normal saline.
HA injection group
Participants will receive intra-articular knee injections under ultrasound guidance with 3 ml of HyLink (SEIKAGAKU CORPORATION, Tokyo, Japan).
Normal saline injection group
Participants will receive intra-articular knee injections under ultrasound guidance with 3 ml of sterile normal saline.
Locations (2)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, Taiwan
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan