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Platelet Rich Plasma for Knee Osteoarthritis

NCT03197441 — Not applicable, Completed, 12 participants, Pei-Yuan Lee, MD

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

RegistryNCT03197441
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment12 (Actual)
SponsorPei-Yuan Lee, MD (Other); collaborators: Aeon Biotechnology Corporation
ConditionsOsteo Arthritis Knee, Platelet-rich Plasma
InterventionsPlatelet-rich plasma (Other)
Datesstart 2016-08-29, primary completion 2018-06-28, completion 2018-06-28, first posted 2017-06-23, last updated 2019-09-06
Locations1 site in Taiwan

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
PRP groupExperimentalOther: Platelet-rich plasmaArthroscopic knee surgery plus intraoperative platelet-rich plasma
  • Platelet-rich plasma (Other): Intraoperative platelet-rich plasma injection during arthroscopic knee surgery

+Outcome measures

Primary outcomes

  • Change in knee function from baseline to postoperative 3 months [3-month postoperative]: Knee function is evaluated using Oswestry Disability Index preoperatively and 3-month postoperatively.

Secondary outcomes

  • Change in knee function from baseline to postoperative 6 months [6-month postoperative]: Knee function is evaluated using Oswestry Disability Index preoperatively and 6-month postoperatively.
  • Change in knee function from baseline to postoperative 12 months [12-month postoperative]: Knee function is evaluated using Oswestry Disability Index preoperatively and 12-month postoperatively.
  • Change in knee pain from baseline to postoperative 3 months [3-month postoperative]: Pain is evaluated using visual analogue scale preoperatively and 3-month postoperatively.
  • Change in knee pain from baseline to postoperative 6 months [6-month postoperative]: Pain is evaluated using visual analogue scale preoperatively and 6-month postoperatively.
  • Change in knee pain from baseline to postoperative 12 months [12-month postoperative]: Pain is evaluated using visual analogue scale preoperatively and 12-month postoperatively.
  • Percentage of patients with regenerated cartilage [12-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 months [6-month postoperative]: Cartilage thickness is assessed by MRI preoperatively and 6-month postoperatively.

+Eligibility

Sex: All, ages: 30 Years to 70 Years

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)

FacilityCityCountryStatus
Show Chwan Memorial HospitalChanghua, ChanghuaTaiwan

+Investigators

My Notes