Clinical trial NCT04201743: An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee
Official title: A Prospective, Double-Blinded, Randomized Controlled Trial of an Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Knee
Amniotic membrane
Allograft
Lead sponsor: Illinois Center for Orthopaedic Research and Education
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 0
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.

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: 90 days, 180 days and 365 days.
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 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.

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).

60 subjects will be enrolled in this study. Subjects will be randomized 1:1 in treatment arms.

Each of the patient will be treated with one time injection to the knee. Methods for collecting data will be through validated patient-reported outcome tools (KOOS, VAS and WOMAC questionnaire) that the patient will complete pre-injection and at specified time intervals after injection: 90 days, 180 days and 365 days.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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:

  1. Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
  2. Intra-articular cortisone (steroid/corticosteroid) injection into the knee joint within 12 weeks of treatment
  3. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
  4. 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

Primary outcomes:
measure: Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
timeFrame: 180 days
measure: Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
timeFrame: 180 days
measure: Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires
timeFrame: 180 days
Secondary outcomes:
measure: Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
timeFrame: 90, 180 and 365 days
measure: Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
timeFrame: 90, 180 and 365 days
measure: Exploratory Endpoint using Validated patient-reported outcome tools questionnaires
timeFrame: 90, 180 and 365 days
Other outcomes:
Locations:
city: Westmont
country: United States
facility: Hinsdale Orthopaedic Associates
state: Illinois
Study officials:
affiliation: Illinois Center for Orthopedic Research and Education (iCORE)
name: Ronak Patel, MD
role: PRINCIPAL_INVESTIGATOR
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.