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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713542
• Other study ID #: 004
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: August 30, 2018

Study information

• Verified date: July 2019
• Source: Arthrex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 30, 2018
• Est. primary completion date: July 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 (> 10°) 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• ACP
Autologous Conditioned Plasma

Other:
• Placebo
Three Normal Saline IA injections of 3-8 mL at 1-week intervals.

Locations

Country	Name	City	State
United States	MedSport University of Michigan Sports Medicine	Ann Arbor	Michigan
United States	Rush University Medical Center	Chicago	Illinois
United States	Columbia Orthopedic Group	Columbia	Missouri
United States	Hawkins Foundation	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Arthrex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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