An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2 mL Injection) and a Placebo (Sterile Saline) in the Treatment of Osteoarthritis of the Knee
NCT ID: NCT04612023
Last Updated: 2021-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
90 participants
INTERVENTIONAL
2020-11-18
2022-07-02
Brief Summary
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Detailed Description
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90 subjects will be enrolled in the study. Subjects will be randomized 1:1:1 in treatment arms.
It compares the dose affect of an amniotic membrane allograft between a 1 mL dose and a 2 mL dose when compared to a placebo of sterile saline in the treatment of osteoarthritis of the knee. This will be offered as a free pain management alternative to patients who meet the inclusion criteria. The results will be determined by validated patient-reported outcome tools (KOOS, VAS, and WOMAC questionnaires) and physical examinations taken before the injection, one month after the injection, three months after the injection, six months after the injection, and one year after the injection. There will be a phone call 24 hours after the injection for every patient participating in the study regarding any potential adverse events.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Inclusion criteria will be all patients age between 21 and 80 years with a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale.
Methods for collecting data will be through validated patient-reported outcome tools that the patient will complete pre-injection and at specified time intervals after injection: 30 days, 90 days, 180 days and 365 days.
Patient will receive a phone call 24 hours after the injection to monitor any immediate potential adverse events.
TREATMENT
TRIPLE
Study Groups
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1 mL NyDYN Injection
30 patients (out of 90) will be blind to and randomly assigned to a 1 mL NyDYN injection.
Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)
Injectable acellular amniotic membrane derived allograft tissue (NuDYN) through routine follow-up with physical examination, pain, function and quality of life measurements and compare dose effects (1 mL versus 2 mL of NuDYN injection) to a placebo (sterile saline) in the treatment of knee osteoarthritis. Injection is minimally invasive and is FDA regulated (HCT/P regulation).
2 mL NuDYN Injection
30 patients (out of 90) will be blind to and randomly assigned to a 2 mL NyDYN injection.
Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)
Injectable acellular amniotic membrane derived allograft tissue (NuDYN) through routine follow-up with physical examination, pain, function and quality of life measurements and compare dose effects (1 mL versus 2 mL of NuDYN injection) to a placebo (sterile saline) in the treatment of knee osteoarthritis. Injection is minimally invasive and is FDA regulated (HCT/P regulation).
Placebo of Sterile Saline
30 patients (out of 90) will be blind to and randomly assigned to a 2 mL dose of sterile saline.
Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)
Injectable acellular amniotic membrane derived allograft tissue (NuDYN) through routine follow-up with physical examination, pain, function and quality of life measurements and compare dose effects (1 mL versus 2 mL of NuDYN injection) to a placebo (sterile saline) in the treatment of knee osteoarthritis. Injection is minimally invasive and is FDA regulated (HCT/P regulation).
Interventions
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Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)
Injectable acellular amniotic membrane derived allograft tissue (NuDYN) through routine follow-up with physical examination, pain, function and quality of life measurements and compare dose effects (1 mL versus 2 mL of NuDYN injection) to a placebo (sterile saline) in the treatment of knee osteoarthritis. Injection is minimally invasive and is FDA regulated (HCT/P regulation).
Eligibility Criteria
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Inclusion Criteria
* Patient must be between the ages of 21 and 80 years old
* Patient must have a diagnosis of osteoarthritis (OA) of the knee defined as grade 1 to 3 on the Kellgren-Lawrence grading scale
Exclusion Criteria
* Patient has a BMI greater than 40 kg/m2, 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
* Patient has rheumatoid arthritis, psoriatic arthritis or diagnosis with any other disorder that is the primary source of their knee pain
* Patient has an autoimmune disease or known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
* Patient has any of the following treatments to the target knee within 12 weeks prior to screening
* Intra-articular hyaluronic acid (HA) injection
* Steroid or platelet rich plasma (PRP) injection
* Use of any investigational drug, device, or biologic
* Patient had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
* Patient has a history of partial or total knee arthroplasty
* Patient has undergone immunotherapy or chemotherapy in the last 5 years, prior radiation at the site, or is currently taking a narcotic medication for any reason
* Patient is pregnant or plans to become pregnant within 365 days of treatment
* Patient has any significant medical condition that would interfere with protocol evaluation and participation
* Patient is a recipient of worker's compensation
* Patient is a current prisoner
21 Years
80 Years
ALL
No
Sponsors
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Illinois Center for Orthopaedic Research and Education
OTHER
Responsible Party
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Eyal Ginesin
Orthopedic Surgeon / Fellow Researcher
Principal Investigators
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Nikil Chari
Role: STUDY_CHAIR
Research Assistant
Jacob Barnhart
Role: STUDY_CHAIR
Research Assistant
Locations
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ICORE
Westmont, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Riboh JC, Saltzman BM, Yanke AB, Cole BJ. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications. Am J Sports Med. 2016 Sep;44(9):2425-34. doi: 10.1177/0363546515612750. Epub 2015 Nov 19.
Vines JB, Aliprantis AO, Gomoll AH, Farr J. Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. J Knee Surg. 2016 Aug;29(6):443-50. doi: 10.1055/s-0035-1569481. Epub 2015 Dec 18.
Other Identifiers
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8212
Identifier Type: -
Identifier Source: org_study_id
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