Platelet Rich Plasma for Knee Osteoarthritis

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197441
• Other study ID #: RA-16028-RD-105065
• Status: Completed
• Phase: N/A
• Start date: August 29, 2016
• Est. completion date: June 28, 2018

Study information

• Verified date: September 2019
• Source: Show Chwan Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 28, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Platelet-rich Plasma

Intervention

Other:
• Platelet-rich plasma
Intraoperative platelet-rich plasma injection during arthroscopic knee surgery

Locations

Country	Name	City	State
Taiwan	Show Chwan Memorial Hospital	Changhua City	Changhua

Sponsors (2)

Lead Sponsor	Collaborator
Pei-Yuan Lee, MD	Aeon Biotechnology Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of patients with regenerated cartilage	Cartilage regeneration is assessed by pathological biopsy during second look surgery at 12-month postoperative.	12-month postoperative
Secondary	Change in cartilage thickness from baseline to postoperative 6 months	Cartilage thickness is assessed by MRI preoperatively and 6-month postoperatively.	6-month postoperative