A Randomized Double-Blind Study Comparing the Safety and Effectiveness of the Intra-Articular Injectable Device ALLOHEAL to Conjuran for Treating Knee Osteoarthritis in Adults Aged 40 to 80

What this Trial Is About

Researchers are evaluating the safety and effectiveness of an intra-articular injectable filler called ALLOHEAL in patients with knee osteoarthritis. This trial aims to show that ALLOHEAL is not less effective than the control device, Conjuran, in reducing joint pain caused by mechanical friction. The trial focuses on adults aged 40 to 80 years who have been diagnosed with knee osteoarthritis and experience significant knee pain. Participants will receive injections of either ALLOHEAL or the active comparator Conjuran directly into the knee joint. The study includes a follow-up period of 24 weeks to assess both the safety and pain-relief effects of the treatments. Evaluations will take place at 6, 10, 16, and 24 weeks after the initial injection, with the primary endpoint being the change in knee pain measured by the Visual Analog Scale VAS at 16 weeks. During the study, participants will undergo clinical assessments including pain evaluations using the VAS scale. Safety data related to the components of ALLOHEAL, including sodium polynucleotide, chitosan, and type I collagen, will be collected throughout the 24-week period. Participants will need to attend scheduled visits for these assessments and comply with study procedures. The total participation time spans approximately six months.

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