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Completed

NCT Number: NCT03485157

Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee

The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee osteoarthritis

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Central Research Associates, Inc, Birmingham, Alabama, United States

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About this study

Each subject will receive 1 injection (micronized dHACM or placebo) and be evaluated for efficacy and safety during a 12-month observation period. A second injection (open-label access to micronized dHACM) will be offered to all subjects at the 180-day, 270-day, and 365-day time points, it may only be used once. Blinding for the first injection treatment allocation will be maintained until the end of the study.

Subjects who receive the open-label access treatment will continue to be followed for 180 days after this second injection, regardless of the time at which treatment was received.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 21 and ≤ 80 years
  • Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale
  • Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
  • Subject must have a VAS pain scale greater than 45

Exclusion criteria

  • Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
  • BMI greater than 40 kg/m^2
  • 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 have been diagnosed with any other disorders that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer
  • Subject has documented history of gout or pseudo-gout
  • Subject has autoimmune disease or a 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
  • 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 a 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 anticoagulant therapy (excluding Plavix or Aspirin)
  • 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

Treatment and study plan

Micronized DHACM

Biological

Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP

Saline

Drug

Injection of 1 mL 0.9% Sodium Chloride, USP

Primary outcomes

  1. Primary Efficacy Endpoint: Change From Baseline in Visual Analog Scale (VAS) for Pain at 90 Days

    Time frame: 90 days

    Visual Analog Scale (VAS): 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain

  2. Primary Efficacy Endpoint: Change From Baseline in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 90 Days

    Time frame: 90 days

    Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales:

    • Pain (5 questions)
    • Stiffness (2 questions)
    • Physical Function (17 questions)

    The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).

    The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96.

    Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  3. Primary Safety Endpoint: Number of Participants With Adverse Events (AEs)

    Time frame: 365 days

    Number of Participants with At Least 1 Treatment Emergent Adverse Event (TEAE) Reported

  4. Primary Safety Endpoint: Number of Participants With Serious Adverse Events (SAEs)

    Time frame: 365 days

    Number of Participants with At Least 1 Serious Treatment Emergent Adverse Event (TEAE) Reported

  5. Primary Safety Endpoint: Number of Participants With Unanticipated Adverse Events

    Time frame: 365 days

    Number of Participants with At Least 1 Unanticipated Treatment Emergent Adverse Event (TEAE) Reported

Secondary outcomes

  1. Secondary Endpoint: Change From Baseline in Visual Analog Scale (VAS) at 180 Days

    Time frame: 180 days

    Visual Analog Scale (VAS) : 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain

  2. Secondary Endpoint:Change From Baseline in WOMAC at 180 Days

    Time frame: 180 days

    Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales:

    • Pain (5 questions)
    • Stiffness (2 questions)
    • Physical Function (17 questions)

    The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).

    The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96.

    Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Other outcomes

  1. Exploratory Endpoint: Change From Baseline in the Visual Analog Scale (VAS) for Pain at 270, and 365 Days

    Time frame: Up to 365 days

    VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain

  2. Exploratory Endpoint: Change From Baseline in the WOMAC Scores at 270 and 365 Days

    Time frame: Up to 365 days

    Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 questions divided into 3 subscales:

    • Pain (5 questions)
    • Stiffness (2 questions)
    • Physical Function (17 questions)

    The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).

    The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score, with a possible total score range of 0-96.

    Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  3. Exploratory Endpoint: Change From Baseline in the Visual Analog Scale (VAS) for Satisfaction at 90, 180, 270 and 365 Days

    Time frame: Up to 365 days

    VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater satisfaction

  4. Exploratory Endpoint: Change From Baseline in the KOOS Scores at 90, 180, 270, and 365 Days

    Time frame: Up to 365 days

    Knee Injury and Osteoarthritis Outcome Score (KOOS): 5 subscales scored on a 5 point scale where the final score is summed and transformed into a 100 point scale with a higher score representing no disability and a lower score representing extreme disability

Sponsors and collaborators

Lead sponsor

MiMedx Group, Inc.

Industry

Registry information

Official study title

A Phase 2B, Prospective, Double-blinded, Randomized Controlled Trial of the Micronized Dehydrated Human Amnion Chorion Membrane Injection as Compared to Saline Placebo Injection in the Treatment of Osteoarthritis of the Knee

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 2, 2018
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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