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

Primary Purpose

Osteoarthritis, Knee

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Acellular amniotic membrane derived allograft injection (NuDYN)

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Amniotic membrane, Allograft

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hinsdale Orthopaedic Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

1 mL NyDYN injection

2 mL NyDYN injection

Arm Description

30 patients (out of 60) will be doubled blinded randomized to this arm and get 1 mL NyDYN injection.

30 patients (out of 60) will be doubled blinded randomized to this arm and get 2 mL NyDYN injection.

Outcomes

Primary Outcome Measures

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.

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).

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.

Secondary Outcome Measures

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.

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).

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.

Full Information

NCT ID

NCT04201743

First Posted

December 8, 2019

Last Updated

September 30, 2020

Sponsor

Illinois Center for Orthopaedic Research and Education

1. Study Identification

Unique Protocol Identification Number

NCT04201743

Brief Title

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

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Resources limited secondary to COVID-19 pandemic.

Study Start Date

March 30, 2020 (Actual)

Primary Completion Date

June 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Illinois Center for Orthopaedic Research and Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

Osteoarthritis, Knee, Amniotic membrane, Allograft

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 mL NyDYN injection

Arm Type

Active Comparator

Arm Description

30 patients (out of 60) will be doubled blinded randomized to this arm and get 1 mL NyDYN injection.

Arm Title

2 mL NyDYN injection

Arm Type

Active Comparator

Arm Description

30 patients (out of 60) will be doubled blinded randomized to this arm and get 2 mL NyDYN injection.

Intervention Type

Drug

Intervention Name(s)

Acellular amniotic membrane derived allograft injection (NuDYN)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires

Description

Time Frame

180 days

Title

Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires

Description

Time Frame

180 days

Title

Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires

Description

Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.

Time Frame

180 days

Secondary Outcome Measure Information:

Title

Exploratory Endpoint using Validated patient-reported outcome tools questionnaires

Description

Time Frame

90, 180 and 365 days

Title

Exploratory Endpoint using Validated patient-reported outcome tools questionnaires

Description

Time Frame

90, 180 and 365 days

Title

Exploratory Endpoint using Validated patient-reported outcome tools questionnaires

Description

Change from baseline Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.

Time Frame

90, 180 and 365 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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: Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening Intra-articular cortisone (steroid/corticosteroid) injection into the knee joint within 12 weeks of treatment 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronak Patel, MD

Organizational Affiliation

Illinois Center for Orthopedic Research and Education (iCORE)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hinsdale Orthopaedic Associates

City

Westmont

State/Province

Illinois

ZIP/Postal Code

60559

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26585668

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.

Results Reference

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PubMed Identifier

26683979

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.

Results Reference

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

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