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NCT03485157 | COMPLETED | Knee Osteoarthritis

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

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

Knee Osteoarthritis

Intervention/treatment

Micronized dHACM

Saline

Phase

PHASE2

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 447 participants
Masking : DOUBLE
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 : 2018-03-27
Estimated Primary Completion Date : 2022-04-19
Estimated Study Completion Date : 2022-04-19

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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/m\^2
  • 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
Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee

Location Details

NCT03485157

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Alabama

Central Research Associates, Inc

Birmingham, Alabama, United States, 35205

Not yet recruiting

United States, Arizona

Fiel Family and Sports Medicine

Tempe, arizona, United States, 85283

Not yet recruiting

United States, California

Horizon Clinical Research

The Table, California, United States, 91942

Not yet recruiting

United States, Connecticut

UConn Health

Farmington, Connecticut, United States, 06030

Not yet recruiting

United States, Connecticut

Bone & Joint Inst. at Hartford Hospital

Hartford, Connecticut, United States, 06106

Not yet recruiting

United States, Florida

Gulfcoast Research Institute

Sarasota, Florida, United States, 34232

Not yet recruiting

United States, Georgia

Paragon Sports Medicine

Atlanta, Georgia, United States, 30327

Not yet recruiting

United States, Illinois

Hinsdale Orthopedics

Hinsdale, Illinois, United States, 60521

Not yet recruiting

United States, Maryland

Arthritis Care Specialist of Maryland

Columbia, Maryland, United States, 21046

Not yet recruiting

United States, Michigan

MedSport

Ann Arbor, Michigan, United States, 48106

Not yet recruiting

United States, New York

Weill Cornell Medicine

New York, New York, United States, 10065

Not yet recruiting

United States, North Carolina

Wake Reseach

Durham, North Carolina, United States, 27704

Not yet recruiting

United States, North Carolina

Wake Research

Raleigh, North Carolina, United States, 27612

Not yet recruiting

United States, Pennsylvania

University Orthopedics Center

Altoona, Pennsylvania, United States, 16602

Not yet recruiting

United States, Pennsylvania

University Orthopedics Center

State College, Pennsylvania, United States, 16801

Not yet recruiting

United States, Texas

SAMMC

Fort Sam Houston, Texas, United States, 78234

Not yet recruiting

United States, Virginia

Ortho Virginia

Richmond, Virginia, United States, 23294