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

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ClinicalTrials.gov Identifier: NCT04612023
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Eyal Ginesin, Illinois Center for Orthopaedic Research and Education

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Other: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN) Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Data will be prospectively collected on all injectable acellular amniotic membrane derived allograft knee performed at our institute. (FDA regulated - HCT/P regulation)

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: 30 days, 90 days, 180 days and 365 days.

Patient will receive a phone call 24 hours after the injection to monitor any immediate potential adverse events.

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Assistants not part of the study used a randomizer generating software to randomly assign a patient a dose. The randomly assigned dose was put in a sealed envelope labeled with the corresponding number and was recorded. Prior to the injection, a medical assistant not involved in the study retrieves the envelope to determine the dose, prepares the injection, then seals the syringe in black tape before giving it to the research staff who then performs the injection.
Primary Purpose: Treatment
Official Title: A Prospective, Double-Blinded, Randomized Controlled Trial of an Amniotic Membrane Allograft Injection Comparing Two Doses (1 mL and 2mL Injection) and a Placebo (Sterile Saline) in the Treatment of Osteoarthritis of the Knee
Actual Study Start Date : November 18, 2020
Estimated Primary Completion Date : April 2, 2022
Estimated Study Completion Date : July 2, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1 mL NyDYN Injection
30 patients (out of 90) will be blind to and randomly assigned to a 1 mL NyDYN injection.
Other: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)
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).

Active Comparator: 2 mL NuDYN Injection
30 patients (out of 90) will be blind to and randomly assigned to a 2 mL NyDYN injection.
Other: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)
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).

Placebo Comparator: Placebo of Sterile Saline
30 patients (out of 90) will be blind to and randomly assigned to a 2 mL dose of sterile saline.
Other: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)
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).




Primary Outcome Measures :
  1. Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires [ Time Frame: 1 year ]
    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.

  2. Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires [ Time Frame: 1 year ]
    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).

  3. Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires [ Time Frame: 1 year ]
    Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.


Secondary Outcome Measures :
  1. Exploratory Endpoint using Validated patient-reported outcome tools questionnaires [ Time Frame: 30, 90, 180, 365 days ]
    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.

  2. Exploratory Endpoint using Validated patient-reported outcome tools questionnaires [ Time Frame: 30, 90, 180, 365 days ]
    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).

  3. Exploratory Endpoint using Validated patient-reported outcome tools questionnaires [ Time Frame: 30, 90, 180, 365 days ]
    Change from baseline Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is a candidate for non-surgical intervention of the knee
  • Patient must be between the ages of 21 and 80 years old
  • Patient must have a diagnosis of osteoarthritis (OA) of the knee defined as grade 1 to 3 on the Kellgren-Lawrence grading scale

Exclusion Criteria:

  • Patient has a diagnosis of osteoarthritis with a Kellgren-Lawrence grade of 4
  • Patient has a BMI greater than 40 kg/m2, 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
  • Patient has rheumatoid arthritis, psoriatic arthritis or diagnosis with any other disorder that is the primary source of their knee pain
  • Patient has an autoimmune disease or known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
  • Patient has any of the following treatments to the target knee within 12 weeks prior to screening
  • Intra-articular hyaluronic acid (HA) injection
  • Steroid or platelet rich plasma (PRP) injection
  • Use of any investigational drug, device, or biologic
  • Patient had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
  • Patient has a history of partial or total knee arthroplasty
  • Patient has undergone immunotherapy or chemotherapy in the last 5 years, prior radiation at the site, or is currently taking a narcotic medication for any reason
  • Patient is pregnant or plans to become pregnant within 365 days of treatment
  • Patient has any significant medical condition that would interfere with protocol evaluation and participation
  • Patient is a recipient of worker's compensation
  • Patient is a current prisoner

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04612023


Contacts
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Contact: Eyal Ginesin, MD 6309292249 eginesin@ibji.com
Contact: Ronak M Patel, MD 6309292249 rpatel@ibji.com

Locations
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United States, Illinois
ICORE Recruiting
Westmont, Illinois, United States, 60559
Contact: Ronak M Patel, MD    630-929-2249    rpatel@ibji.com   
Contact: Eyal Ginesin, MD    6309292249    eginesin@ibji.com   
Sponsors and Collaborators
Illinois Center for Orthopaedic Research and Education
Investigators
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Study Chair: Nikil Chari Research Assistant
Study Chair: Jacob Barnhart Research Assistant
Publications:
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Responsible Party: Eyal Ginesin, Orthopedic Surgeon / Fellow Researcher, Illinois Center for Orthopaedic Research and Education
ClinicalTrials.gov Identifier: NCT04612023    
Other Study ID Numbers: 8212
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eyal Ginesin, Illinois Center for Orthopaedic Research and Education:
osteoarthritis
amniotic fluid
amniotic allograft
knee
amniotic membrane
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases