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Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ACP

Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The subject is 18 to 70 years of age.
The subject presents with complaints of continued pain of primary knee for at least 6 weeks.
The subject has documented radiographs evidence of Osteoarthritis (OA) in the tibio-femoral or patella-femoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 24 weeks of screening.
The subject has a WOMAC pain score of at least 8 out of 20 and at least moderate pain (a score of 2) for at least 2 questions on activities

Exclusion Criteria:

Grade I and IV on the knee Kellgren-Lawrence grading scale
Subject has clinically 3+ effusion of the target knee (stroke test grading system).
Subject has significant (> 10⁰) valgus or varus deformities as evidenced by standard of care X-ray.
Subject has had systemic or IA injection of corticosteroids in any joint within three months prior to screening.
Viscosupplementation in any joint in the past six months.
Subject has an increased risk for post- procedure bleeding (e.g., bleeding disorder or taking anticoagulants except low-dose aspirin).
Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months
Subject has inflammatory disease of either knee other than OA.
Subject with underlying medical conditions that could interfere with the evaluation of the outcome.
Subject with positive pregnancy test, or breast feeding.
Subject with plans to participate in other clinical trial involving medical or surgical intervention in the next 12 months.
Subject with any condition (including cognitive impairment) that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Subject has rheumatoid arthritis or gout
Subject has a history of or a current infection at the affected joint.
Subject with plans to undergo any elective orthopedic surgery in the next 12 months.
Subject requires pain management therapy (with the exception of acetaminophen) not related to the target knee.

Sites / Locations

Rush University Medical Center
MedSport University of Michigan Sports Medicine
Columbia Orthopedic Group
Hawkins Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Autologous Conditioned Plasma (ACP)

Normal Saline (NS)

Arm Description

3 Intra-articular (IA) injections at 1 week intervals

3 NS Intra-articular (IA) injections at 1 week intervals

Outcomes

Primary Outcome Measures

Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey

The WOMAC Pain score will be used to measure outcome, the score ranges from 0 to 20. The higher the score indicates greater pain.

Secondary Outcome Measures

Full Information

NCT ID

NCT02713542

First Posted

February 4, 2016

Last Updated

July 19, 2019

Sponsor

Arthrex, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02713542

Brief Title

Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)

Official Title

Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

July 2016 (undefined)

Primary Completion Date

July 2, 2018 (Actual)

Study Completion Date

August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arthrex, Inc.

4. Oversight

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This study is primarily investigating the effectiveness of Autologous Conditioned Plasma (ACP) Intra-articular (IA) in patients with Osteoarthritis (OA) in the knee.

Detailed Description

This study is a prospective, multi center randomized double blind, two arm study. 90 subjects will be randomized to receive injections of either Autologous Conditioned Plasma Intra-articular or the control.

6. Conditions and Keywords

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

Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Autologous Conditioned Plasma (ACP)

Arm Type

Experimental

Arm Description

3 Intra-articular (IA) injections at 1 week intervals

Arm Title

Normal Saline (NS)

Arm Type

Placebo Comparator

Arm Description

3 NS Intra-articular (IA) injections at 1 week intervals

Intervention Type

Device

Intervention Name(s)

ACP

Intervention Description

Autologous Conditioned Plasma

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Normal Saline

Intervention Description

Three Normal Saline IA injections of 3-8 mL at 1-week intervals.

Primary Outcome Measure Information:

Title

Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey

Description

The WOMAC Pain score will be used to measure outcome, the score ranges from 0 to 20. The higher the score indicates greater pain.

Time Frame

6 month visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The subject is 18 to 70 years of age. The subject presents with complaints of continued pain of primary knee for at least 6 weeks. The subject has documented radiographs evidence of Osteoarthritis (OA) in the tibio-femoral or patella-femoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 24 weeks of screening. The subject has a WOMAC pain score of at least 8 out of 20 and at least moderate pain (a score of 2) for at least 2 questions on activities Exclusion Criteria: Grade I and IV on the knee Kellgren-Lawrence grading scale Subject has clinically 3+ effusion of the target knee (stroke test grading system). Subject has significant (> 10⁰) valgus or varus deformities as evidenced by standard of care X-ray. Subject has had systemic or IA injection of corticosteroids in any joint within three months prior to screening. Viscosupplementation in any joint in the past six months. Subject has an increased risk for post- procedure bleeding (e.g., bleeding disorder or taking anticoagulants except low-dose aspirin). Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months Subject has inflammatory disease of either knee other than OA. Subject with underlying medical conditions that could interfere with the evaluation of the outcome. Subject with positive pregnancy test, or breast feeding. Subject with plans to participate in other clinical trial involving medical or surgical intervention in the next 12 months. Subject with any condition (including cognitive impairment) that, in the opinion of the investigator, might interfere with the evaluation of the study objectives. Subject has rheumatoid arthritis or gout Subject has a history of or a current infection at the affected joint. Subject with plans to undergo any elective orthopedic surgery in the next 12 months. Subject requires pain management therapy (with the exception of acetaminophen) not related to the target knee.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Smith, MD

Organizational Affiliation

Columbias Orthopedic Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

MedSport University of Michigan Sports Medicine

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

Facility Name

Columbia Orthopedic Group

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65201

Country

United States

Facility Name

Hawkins Foundation

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)

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