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CompletedNCT03197441Updated Sep 6, 2019

Platelet Rich Plasma for Knee Osteoarthritis

An interventional study of Platelet-rich plasma in Osteo Arthritis Knee and Platelet-rich Plasma, sponsored by Pei-Yuan Lee, MD. Completed at 1 site in Taiwan. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-06.

Sponsored by Pei-Yuan Lee, MD · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Aug 2016, registered Apr 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
30 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteo Arthritis Knee
  • Platelet-rich Plasma

Keywords

  • Platelet-rich plasma
  • Osteoarthritis Knee
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 12 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Pei-Yuan Lee, MD is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age between 30 and 70 years
  • With diagnosis of osteoarthritis, grade II\~grade IV, II-III medial compartment

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    PRP group

    Arthroscopic knee surgery plus intraoperative platelet-rich plasma

    Other: Platelet-rich plasma

Interventions

  • OtherPlatelet-rich plasma

    Intraoperative platelet-rich plasma injection during arthroscopic knee surgery

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Percentage of patients with regenerated cartilage

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

    Time frame: 12-month postoperative

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

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

    Time frame: 6-month postoperative

07

Study locations

1 site
  • Show Chwan Memorial Hospital
    Changhua City, Changhua 500, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03197441
Lead sponsor
Pei-Yuan Lee, MD
Collaborators
Aeon Biotechnology Corporation
Responsible party
Pei-Yuan Lee, MD (Superintendent, Show Chwan Memorial Hospital) — Sponsor-investigator
First posted
Jun 23, 2017
Start date
Aug 29, 2016
Primary completion
Jun 28, 2018
Completion
Jun 28, 2018
Last update
Sep 6, 2019

Study contacts

Pei-Yuan Lee, MD
study chair · Show Chwan Memorial Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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