Platelet Rich Plasma for Knee Osteoarthritis

N/ACompletedNCT03197441

Pei-Yuan Lee, MD12 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteo Arthritis Knee Platelet-rich Plasma

Interventions

Platelet-rich plasmaOTHER

Intraoperative platelet-rich plasma injection during arthroscopic knee surgery

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Show Chwan Memorial Hospital

Changhua, Changhua, Taiwan

Outcomes

Primary Outcomes

Change in knee function from baseline to postoperative 3 months

Knee function is evaluated using Oswestry Disability Index preoperatively and 3-month postoperatively.

Time frame: 3-month postoperative

Secondary Outcomes

Change in knee function from baseline to postoperative 6 months

Knee function is evaluated using Oswestry Disability Index preoperatively and 6-month postoperatively.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12-month postoperative

Percentage of patients with regenerated cartilage

Cartilage regeneration is assessed by pathological biopsy during second look surgery at 12-month postoperative.

Data from ClinicalTrials.gov

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