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Platelet Rich Plasma for Knee Osteoarthritis

Not Applicable
Completed
Conditions
Platelet-rich Plasma
Osteo Arthritis Knee
Interventions
Other: Platelet-rich plasma
Registration Number
NCT03197441
Lead Sponsor
Pei-Yuan Lee, MD
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
PRP groupPlatelet-rich plasmaArthroscopic knee surgery plus intraoperative platelet-rich plasma
Primary Outcome Measures
NameTimeMethod
Change in knee function from baseline to postoperative 3 months3-month postoperative

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

Secondary Outcome Measures
NameTimeMethod
Change in knee function from baseline to postoperative 6 months6-month postoperative

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

Change in knee function from baseline to postoperative 12 months12-month postoperative

Knee function is evaluated using Oswestry Disability Index preoperatively and 12-month postoperatively.

Change in knee pain from baseline to postoperative 3 months3-month postoperative

Pain is evaluated using visual analogue scale preoperatively and 3-month postoperatively.

Change in knee pain from baseline to postoperative 6 months6-month postoperative

Pain is evaluated using visual analogue scale preoperatively and 6-month postoperatively.

Change in knee pain from baseline to postoperative 12 months12-month postoperative

Pain is evaluated using visual analogue scale preoperatively and 12-month postoperatively.

Percentage of patients with regenerated cartilage12-month postoperative

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

Change in cartilage thickness from baseline to postoperative 6 months6-month postoperative

Cartilage thickness is assessed by MRI preoperatively and 6-month postoperatively.

Trial Locations

Locations (1)

Show Chwan Memorial Hospital

🇨🇳

Changhua City, Changhua, Taiwan

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