An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Double-Blinded, Randomized Controlled Trial of an Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Acellular amniotic membrane derived allograft injection (NuDYN)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 21 to 80 years Diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale Exclusion Criteria: Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale BMI greater than 40 kg/m2 Subject has active infection at the injection site Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol) and requires other therapy. Subject has rheumatoid arthritis, psoriatic arthritis or has been diagnosed with any other disorder that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor or cancer Subject has documented history of gout or pseudo-gout Subject has an autoimmune disease or known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV Subject has received any of the following to the target knee: Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening Intra-articular cortisone (steroid/corticosteroid) injection into the knee joint within 12 weeks of treatment Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment History of partial or total knee arthroplasty Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment Subject has a history of immunosuppressive or chemotherapy in the last 5 years Subject has had prior radiation at the site Subject is currently taking narcotic medication for any reason. Subject is pregnant or plans to become pregnant within 365 days of treatment Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation Subject is a worker's compensation patient Subject is a prisoner

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Data will be prospectively collected on all injectable acellular amniotic membrane derived allograft knee performed at our institute. Inclusion criteria will be all patients age between 21 and 80 years with a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale. Methods for collecting data will be through validated patient-reported outcome tools that the patient will complete pre-injection and at specified time intervals after injection: 90 days, 180 days and 365 days.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 mL NyDYN injection<br>30 patients (out of 60) will be doubled blinded randomized to this arm and get 1 mL NyDYN injection. | Drug: Acellular amniotic membrane derived allograft injection (NuDYN)<br>* 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.<br>|
| Active Comparator: 2 mL NyDYN injection<br>30 patients (out of 60) will be doubled blinded randomized to this arm and get 2 mL NyDYN injection. | Drug: Acellular amniotic membrane derived allograft injection (NuDYN)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 90, 180 and 365 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Knee, Amniotic membrane, Allograft