Clinical trial NCT04612023: 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
Official title: A Prospective, Double-Blinded, Randomized Controlled Trial of an Amniotic Membrane Allograft Injection Comparing Two Doses (1 mL and 2mL Injection) and a Placebo (Sterile Saline) in the Treatment of Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Keywords: osteoarthritis
amniotic fluid
amniotic allograft
knee
amniotic membrane
Lead sponsor: Illinois Center for Orthopaedic Research and Education
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Data will be prospectively collected on all injectable acellular amniotic membrane derived allograft knee performed at our institute. (FDA regulated - HCT/P regulation)

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.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the dose effect of a single injectable acellular amniotic membrane derived allograft 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 when compared to a placebo.

Detailed description: It is a prospective, double blinded, Randomized Controlled Trial study. Data will be prospectively collected of all injectable acellular amniotic membrane derived allograft knee performed at our institute (1 vs 2 mL).

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.

Eligibility criteria: Inclusion Criteria:

* Patient is a candidate for non-surgical intervention of the knee
* 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 diagnosis of osteoarthritis with a Kellgren-Lawrence grade of 4
* 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

Primary outcomes:
measure: Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
timeFrame: 1 year
measure: Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
timeFrame: 1 year
measure: Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
timeFrame: 1 year
Secondary outcomes:
measure: Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
timeFrame: 30, 90, 180, 365 days
measure: Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
timeFrame: 30, 90, 180, 365 days
measure: Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
timeFrame: 30, 90, 180, 365 days
Other outcomes:
Locations:
city: Westmont
country: United States
facility: ICORE
state: Illinois
Study officials:
affiliation: Research Assistant
name: Nikil Chari
role: STUDY_CHAIR
affiliation: Research Assistant
name: Jacob Barnhart
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.