The purpose of this study is to determine the dose effect of a single injectable acellular amniotic membrane derived allograft injection 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.
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). 60 subjects will be enrolled in this study. Subjects will be randomized 1:1 in treatment arms. Each of the patient will be treated with one time injection to the knee. Methods for collecting data will be through validated patient-reported outcome tools (KOOS, VAS and WOMAC questionnaire) that the patient will complete pre-injection and at specified time intervals after injection: 90 days, 180 days and 365 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Injectable acellular amniotic membrane derived allograft (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) in the treatment of knee osteoarthritis.
Hinsdale Orthopaedic Associates
Westmont, Illinois, United States
Primary 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: 180 days
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: 180 days
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: 180 days
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: 90, 180 and 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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 90, 180 and 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: 90, 180 and 365 days