Platelet Rich Plasma for Knee Osteoarthritis

Intraoperative Platelet Rich Plasma Injection in Arthroscopic Surgery for Osteoarthritis of the Knee

This study aimed to analyze the effect of platelet-rich plasma (PRP) on knee osteoarthritis. Eligible patients will undertake arthroscopic knee surgery plus intraoperative PRP and also receive second look surgery and intraoperative biopsy.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee; Platelet-rich Plasma
• Intervention / Treatment: Other: Platelet-rich plasma

Detailed Description

Osteoarthritis is a chronic disease defined by progressive degradation of the joint as well as loss of cartilage on joint surfaces. The degeneration that occurs in the joint leads to changes in the catabolic and anabolic activity of chondrocytes. Osteoarthritis may induce pain, stiffness and limitation in range of motion of the joint and also may impact the quality of life. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration in orthopedic and oral surgery. Although several studies have assessed the effects of PRP on knee osteoarthritis, a higher level of evidence has not been provided. This study aimed to analyze the effect of PRP on knee osteoarthritis. After performing arthroscopic knee surgery plus intraoperative PRP in eligible patients, a second look arthroscopic surgery with intraoperative biopsy will be arranged 6 months later. Pre- and post-operative imaging and clinical outcomes will also be compared.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Changhua
    • Changhua City, Changhua, Taiwan, 500
      • Show Chwan Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 30 and 70 years
• With diagnosis of osteoarthritis, grade II~grade IV, II-III medial compartment

Exclusion Criteria:

• Lateral compartment and patellofemoral joint osteoarthritis
• With prior history of knee surgery
• Severe varus deformity
• With current or prior history of traum or infection at the knee
• With current or prior history of cancer
• With current or prior history of hematological disease
• Pregnancy
• Patients who will not cooperate with one-year followup

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP group; Arthroscopic knee surgery plus intraoperative platelet-rich plasma	Other: Platelet-rich plasma; Intraoperative platelet-rich plasma injection during arthroscopic knee surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knee function from baseline to postoperative 3 months	Knee function is evaluated using Oswestry Disability Index preoperatively and 3-month postoperatively.	3-month postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knee function from baseline to postoperative 6 months	Knee function is evaluated using Oswestry Disability Index preoperatively and 6-month postoperatively.	6-month postoperative
Change in knee function from baseline to postoperative 12 months	Knee function is evaluated using Oswestry Disability Index preoperatively and 12-month postoperatively.	12-month postoperative
Change in knee pain from baseline to postoperative 3 months	Pain is evaluated using visual analogue scale preoperatively and 3-month postoperatively.	3-month postoperative
Change in knee pain from baseline to postoperative 6 months	Pain is evaluated using visual analogue scale preoperatively and 6-month postoperatively.	6-month postoperative
Change in knee pain from baseline to postoperative 12 months	Pain is evaluated using visual analogue scale preoperatively and 12-month postoperatively.	12-month postoperative
Percentage of patients with regenerated cartilage	Cartilage regeneration is assessed by pathological biopsy during second look surgery at 12-month postoperative.	12-month postoperative
Change in cartilage thickness from baseline to postoperative 6 months	Cartilage thickness is assessed by MRI preoperatively and 6-month postoperatively.	6-month postoperative

Collaborators and Investigators

• Sponsor: Pei-Yuan Lee, MD
• Collaborators: Aeon Biotechnology Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2016
• Primary Completion (Actual): June 28, 2018
• Study Completion (Actual): June 28, 2018

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Platelet-rich plasma; Osteoarthritis Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: RA-16028-RD-105065

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: No
• Studies a U.S. FDA-regulated device product: No