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

Withdrawn before enrolling · Phase 4

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT04201743

Run by

Illinois Center for Orthopaedic Research and Education

People needed

0

Starts

2020-03-30

Expected to finish

2021-12-01

Last updated by the study team

2020-10-05

Who can join

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

You may qualify if…

• Age of 21 to 80 years
• Diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale

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/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:
• Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
• Intra-articular cortisone (steroid/corticosteroid) injection into the knee joint within 12 weeks of treatment
• 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 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

Where it is running

• Hinsdale Orthopaedic Associates — Westmont, Illinois, United States

Full record on ClinicalTrials.gov

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