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

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ClinicalTrials.gov Identifier: NCT04201743
Recruitment Status : Not yet recruiting
First Posted : December 17, 2019
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Ronak M. Patel, 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 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Acellular amniotic membrane derived allograft injection (NuDYN) Phase 4

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).

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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.

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 (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: 1 mL NyDYN injection
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)
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.

Active Comparator: 2 mL NyDYN injection
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)
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.




Primary Outcome Measures :
  1. Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires [ Time Frame: 180 days ]
    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: 180 days ]
    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: 180 days ]
    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: 90, 180 and 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: 90, 180 and 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: 90, 180 and 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:

  • 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:

    1. Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
    2. Intra-articular cortisone (steroid/corticosteroid) injection into the knee joint within 12 weeks of treatment
    3. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
    4. 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

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): NCT04201743


Contacts
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Contact: Ronak Patel, MD 630-728-8961 ronak.patel@hoasc.com

Locations
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United States, Illinois
Hinsdale Orthopaedic Associates
Westmont, Illinois, United States, 60559
Sponsors and Collaborators
Illinois Center for Orthopaedic Research and Education
Investigators
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Principal Investigator: Ronak Patel, MD Illinois Center for Orthopedic Research and Education (iCORE)
Publications:
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Responsible Party: Ronak M. Patel, President, Illinois Center for Orthopaedic Research and Education
ClinicalTrials.gov Identifier: NCT04201743    
Other Study ID Numbers: 199608
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
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 Ronak M. Patel, Illinois Center for Orthopaedic Research and Education:
Osteoarthritis
Knee
Amniotic membrane
Allograft
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases