ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03485157
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Micronized DHACM Drug: Saline Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Micronized dHACM
Injection of micronized dHACM
Biological: Micronized DHACM
Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP

Placebo Comparator: Saline
Injection of 0.9% Sodium Chloride Injection, USP
Drug: Saline
Injection of 1 mL 0.9% Sodium Chloride, USP




Primary Outcome Measures :
  1. Primary Efficacy Endpoint: Change from baseline in Visual Analog Scale (VAS) for Pain at 90 days [ Time Frame: 90 days ]
    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 items divided into 3 subscales:

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

    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.

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


  3. Primary Safety Endpoint: The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events [ Time Frame: 365 days ]
    The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events


Secondary Outcome Measures :
  1. Secondary Endpoint: Change from baseline in Visual Analog Scale (VAS) at 180 days [ Time Frame: 180 days ]
    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 items divided into 3 subscales:

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

    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.

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



Other Outcome Measures:
  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 items divided into 3 subscales:

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

    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.

    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

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

Exclusion Criteria:

  1. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
  2. BMI greater than 40 kg/m2
  3. Subject has active infection at the injection site
  4. Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol®) and requires other therapy.
  5. 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
  6. Subject has documented history of gout or pseudo-gout
  7. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
  8. 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. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
    3. Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
    4. History of a total knee arthroplasty
  9. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
  10. Subject has a history of immunosuppressive or chemotherapy in the last 5 years
  11. Subject has had prior radiation at the site
  12. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
  13. Subject is pregnant or plans to become pregnant within 365 days of treatment
  14. Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
  15. Subject is a worker's compensation patient
  16. 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): NCT03485157


Contacts
Contact: Stan Harris 770-651-9100 sharris@mimedx.com
Contact: Kim Kot 770-651-9100 kkot@mimedx.com

Locations
United States, Alabama
Central Research Associates, Inc Recruiting
Birmingham, Alabama, United States, 35205
Contact: Shellie Tasllie, LPN         
United States, California
Horizon Clinical Research Recruiting
La Mesa, California, United States, 91942
Contact: Marisa Radeke         
United States, Florida
Gulfcoast Research Institute Recruiting
Sarasota, Florida, United States, 34232
Contact: Patricia D'Alessio         
United States, Georgia
Paragon Sports Medicine Recruiting
Atlanta, Georgia, United States, 30327
Contact: Jay Sturm         
United States, Illinois
Hinsdale Orthopedics Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Linda Silva         
United States, Michigan
MedSport Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Ranae Hoeft         
United States, Pennsylvania
University Orthopedics Center Recruiting
Altoona, Pennsylvania, United States, 16602
Contact: Penny Adams         
University Orthopedics Center Recruiting
State College, Pennsylvania, United States, 16801
Contact: Sue Jepson         
United States, Virginia
Ortho Virginia Not yet recruiting
Richmond, Virginia, United States, 23294
Contact: Lisa Thorp, CST         
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
Principal Investigator: Alfred C Gellhorn, MD Weill Cornell Medicine

Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT03485157     History of Changes
Other Study ID Numbers: AIOA001
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases