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Comparison of the Efficacy of Intra-articular Injection of Human Amniotic Suspension Allograft and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis: A Prospective, Double-blind, Randomized Controlled Trial
A double-blind, randomized controlled trial designed to evaluate the symptomatic modulating efficacy of amniotic suspension allograft (ASA) in comparison to platelet-rich plasma (PRP), hyaluronic acid (HA) and normal saline (NS) in the injection treatment of knee osteoarthritis. The hypothesis is that ASA would provide the greatest functional improvement.
At least 150 subjects with osteoarthritic knee will be recruited and computer randomized 1:1:1:1 to single injection of ASA (40mg), ASA (20mg), PRP + HA, and NS groups. Both subjects and evaluaters were blinded to allocations. Functional and radiologic outcomes were measured at baseline, and 1 week, 1, 3, 6, 12 months postinjection.
Age
20 - 80 years
Sex
ALL
Healthy Volunteers
No
Start Date
January 1, 2021
Primary Completion Date
January 31, 2022
Completion Date
January 31, 2023
Last Updated
January 6, 2021
150
ESTIMATED participants
Human amniotic suspension allograft (ASA)
BIOLOGICAL
Lead Sponsor
Kaohsiung Veterans General Hospital.
NCT06857123
NCT07347821
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07183475