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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: Acellular amniotic membrane derived allograft injection (NuDYN)

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Westmont, Illinois, United States, 60559
      • Hinsdale Orthopaedic Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1 mL NyDYN injection; 30 patients (out of 60) will be doubled blinded randomized to this arm and get 1 mL NyDYN injection.	Drug: Acellular amniotic membrane derived allograft injection (NuDYN); Injectable acellular amniotic membrane derived allograft (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) in the treatment of knee osteoarthritis.
Active Comparator: 2 mL NyDYN injection; 30 patients (out of 60) will be doubled blinded randomized to this arm and get 2 mL NyDYN injection.	Drug: Acellular amniotic membrane derived allograft injection (NuDYN); Injectable acellular amniotic membrane derived allograft (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) in the treatment of knee osteoarthritis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires	Knee injury and Osteoarthritis Outcome Score (KOOS)- assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.	180 days
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- assess the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. it is a 0 (worst)-96 scale (best).	180 days
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires	Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires	Change from baseline Knee injury and Osteoarthritis Outcome Score (KOOS)- assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.	90, 180 and 365 days
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires	Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- assess the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. it is a 0 (worst)-96 scale (best).	90, 180 and 365 days
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires	Change from baseline Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.	90, 180 and 365 days

Collaborators and Investigators

• Sponsor: Illinois Center for Orthopaedic Research and Education
• Investigators: Principal Investigator: Ronak Patel, MD, Illinois Center for Orthopedic Research and Education (iCORE)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 8, 2019
• First Submitted That Met QC Criteria: December 14, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee; Allograft; Amniotic membrane
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 199608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No