Status:
COMPLETED
Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee
Lead Sponsor:
MiMedx Group, Inc.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
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...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2022
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT03485157
Start Date
March 27 2018
End Date
April 19 2022
Last Update
December 11 2023
Active Locations (17)
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1
Central Research Associates, Inc
Birmingham, Alabama, United States, 35205
2
Fiel Family and Sports Medicine
Tempe, Arizona, United States, 85283
3
Horizon Clinical Research
La Mesa, California, United States, 91942
4
UConn Health
Farmington, Connecticut, United States, 06030