The purpose of this study is to determine the dose effect of a single injectable acellular amniotic membrane derived allograft for the treatment of knee osteoarthritis and to confirm whether the use of 2 mL of the same amniotic injection offers a statistically significant advantage over the 1 mL injection when compared to a placebo.
It is a prospective, double blinded, Randomized Controlled Trial study. Data will be prospectively collected of all injectable acellular amniotic membrane derived allograft knee performed at our institute (1 vs 2 mL). 90 subjects will be enrolled in the study. Subjects will be randomized 1:1:1 in treatment arms. It compares the dose affect of an amniotic membrane allograft between a 1 mL dose and a 2 mL dose when compared to a placebo of sterile saline in the treatment of osteoarthritis of the knee. This will be offered as a free pain management alternative to patients who meet the inclusion criteria. The results will be determined by validated patient-reported outcome tools (KOOS, VAS, and WOMAC questionnaires) and physical examinations taken before the injection, one month after the injection, three months after the injection, six months after the injection, and one year after the injection. There will be a phone call 24 hours after the injection for every patient participating in the study regarding any potential adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
Injectable acellular amniotic membrane derived allograft tissue (NuDYN) through routine follow-up with physical examination, pain, function and quality of life measurements and compare dose effects (1 mL versus 2 mL of NuDYN injection) to a placebo (sterile saline) in the treatment of knee osteoarthritis. Injection is minimally invasive and is FDA regulated (HCT/P regulation).
ICORE
Westmont, Illinois, United States
RECRUITINGPrimary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Knee injury and Osteoarthritis Outcome Score (KOOS)- assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Time frame: 1 year
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- assess the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. it is a 0 (worst)-96 scale (best).
Time frame: 1 year
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.
Time frame: 1 year
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Change from baseline Knee injury and Osteoarthritis Outcome Score (KOOS)- assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Time frame: 30, 90, 180, 365 days
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- assess the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. it is a 0 (worst)-96 scale (best).
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Time frame: 30, 90, 180, 365 days
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
Change from baseline Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.
Time frame: 30, 90, 180, 365 days