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

Completed · Phase 2

Conditions studied: Knee Osteoarthritis

In brief

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

Key facts

Study ID

NCT03485157

Run by

MiMedx Group, Inc.

People needed

447

Starts

2018-03-27

Expected to finish

2022-04-19

Last updated by the study team

2023-12-11

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Central Research Associates, Inc — Birmingham, Alabama, United States
• Fiel Family and Sports Medicine — Tempe, Arizona, United States
• Horizon Clinical Research — La Mesa, California, United States
• UConn Health — Farmington, Connecticut, United States
• Bone & Joint Inst. at Hartford Hospital — Hartford, Connecticut, United States
• Gulfcoast Research Institute — Sarasota, Florida, United States
• Paragon Sports Medicine — Atlanta, Georgia, United States
• Hinsdale Orthopedics — Hinsdale, Illinois, United States
• Arthritis Care Specialist of Maryland — Columbia, Maryland, United States
• MedSport — Ann Arbor, Michigan, United States
• Weill Cornell Medicine — New York, New York, United States
• Wake Reseach — Durham, North Carolina, United States
• Wake Research — Raleigh, North Carolina, United States
• University Orthopedics Center — Altoona, Pennsylvania, United States
• University Orthopedics Center — State College, Pennsylvania, United States
• SAMMC — Fort Sam Houston, Texas, United States
• Ortho Virginia — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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