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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: ACP; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • MedSport University of Michigan Sports Medicine
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Columbia Orthopedic Group
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Hawkins Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subject is 18 to 70 years of age.
2. The subject presents with complaints of continued pain of primary knee for at least 6 weeks.
3. 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.
4. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Autologous Conditioned Plasma (ACP); 3 Intra-articular (IA) injections at 1 week intervals	Device: ACP; Autologous Conditioned Plasma
PLACEBO_COMPARATOR: Normal Saline (NS); 3 NS Intra-articular (IA) injections at 1 week intervals	Other: Placebo; Three Normal Saline IA injections of 3-8 mL at 1-week intervals.; Other Names: Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 month visit

Collaborators and Investigators

• Sponsor: Arthrex, Inc.
• Investigators: Principal Investigator: Patrick Smith, MD, Columbias Orthopedic Group

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): July 2, 2018
• Study Completion (ACTUAL): August 30, 2018

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (ESTIMATE): March 18, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2019
• Last Update Submitted That Met QC Criteria: July 19, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 004

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 device product: Yes