Platelet Rich Plasma for Knee Osteoarthritis

NCT ID: NCT03197441

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-29
• Study Completion Date: 2018-06-28

Brief 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.

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.

Conditions

Osteo Arthritis Knee; Platelet-rich Plasma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRP group

Arthroscopic knee surgery plus intraoperative platelet-rich plasma

Group Type: EXPERIMENTAL

Platelet-rich plasma

Intervention Type: OTHER

Intraoperative platelet-rich plasma injection during arthroscopic knee surgery

Interventions

Platelet-rich plasma

Intraoperative platelet-rich plasma injection during arthroscopic knee surgery

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aeon Biotechnology Corporation

INDUSTRY

Sponsor Role: collaborator

Pei-Yuan Lee, MD

OTHER

Sponsor Role: lead

Responsible Party

Pei-Yuan Lee, MD

Superintendent

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pei-Yuan Lee, MD

Role: STUDY_CHAIR

Show Chwan Memorial Hospital

Locations

Show Chwan Memorial Hospital

Changhua, Changhua, Taiwan

Countries

Taiwan

Other Identifiers

RA-16028-RD-105065

Identifier Type: -

Identifier Source: org_study_id