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Completed

NCT Number: NCT03197441

Platelet Rich Plasma for Knee Osteoarthritis

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.

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Key information

Conditions

Osteo Arthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Platelet-Rich Plasma Rheumatic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Show Chwan Memorial Hospital

Changhua, 500, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet-rich plasma

Other

Intraoperative platelet-rich plasma injection during arthroscopic knee surgery

Primary outcomes

  1. Change in knee function from baseline to postoperative 3 months

    Time frame: 3-month postoperative

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

Secondary outcomes

  1. Change in knee function from baseline to postoperative 6 months

    Time frame: 6-month postoperative

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

  2. Change in knee function from baseline to postoperative 12 months

    Time frame: 12-month postoperative

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

  3. Change in knee pain from baseline to postoperative 3 months

    Time frame: 3-month postoperative

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

  4. Change in knee pain from baseline to postoperative 6 months

    Time frame: 6-month postoperative

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

  5. Change in knee pain from baseline to postoperative 12 months

    Time frame: 12-month postoperative

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

  6. Percentage of patients with regenerated cartilage

    Time frame: 12-month postoperative

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

  7. Change in cartilage thickness from baseline to postoperative 6 months

    Time frame: 6-month postoperative

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

Sponsors and collaborators

Lead sponsor

Pei-Yuan Lee, MD

Other

Collaborators

  • Aeon Biotechnology Corporation

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 23, 2017
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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