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Platelet Rich Plasma for Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03197441
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Collaborator:
Aeon Biotechnology Corporation
Information provided by (Responsible Party):
Pei-Yuan Lee, MD, Show Chwan Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Platelet-rich Plasma Other: Platelet-rich plasma Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraoperative Platelet Rich Plasma Injection in Arthroscopic Surgery for Osteoarthritis of the Knee
Actual Study Start Date : August 29, 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: PRP group
Arthroscopic knee surgery plus intraoperative platelet-rich plasma
Other: Platelet-rich plasma
Intraoperative platelet-rich plasma injection during arthroscopic knee surgery




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197441


Contacts
Contact: Chang-Han Chuang, MD +886-975611794 skyman889@gmail.com

Locations
Taiwan
Show Chwan Memorial Hospital Recruiting
Changhua City, Changhua, Taiwan, 500
Contact: Chang-Han Chuang, MD    +886-975611794    skyman889@gmail.com   
Sponsors and Collaborators
Pei-Yuan Lee, MD
Aeon Biotechnology Corporation
Investigators
Study Chair: Pei-Yuan Lee, MD Show Chwan Memorial Hospital

Responsible Party: Pei-Yuan Lee, MD, Superintendent, Show Chwan Memorial Hospital
ClinicalTrials.gov Identifier: NCT03197441     History of Changes
Other Study ID Numbers: RA-16028-RD-105065
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pei-Yuan Lee, MD, Show Chwan Memorial Hospital:
Platelet-rich plasma
Osteoarthritis Knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases