Platelet Rich Plasma for Knee Osteoarthritis

• Sponsor: Pei-Yuan Lee, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT03197441
• Collaborator: Aeon Biotechnology Corporation (Industry)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 21.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• 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: Aug 29, 2016
• Actual Primary Completion Date: Jun 28, 2018
• Actual Study Completion Date: Jun 28, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. Percentage of patients with regenerated cartilage [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 [6-month postoperative]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Show Chwan Memorial Hospital	Changhua City	Changhua	Taiwan	500

Sponsors and Collaborators

• Pei-Yuan Lee, MD
• Aeon Biotechnology Corporation

Investigators

• Study Chair: Pei-Yuan Lee, MD, Show Chwan Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pei-Yuan Lee, MD, Superintendent, Show Chwan Memorial Hospital
• ClinicalTrials.gov Identifier: NCT03197441
• Other Study ID Numbers: RA-16028-RD-105065
• First Posted: Jun 23, 2017
• Last Update Posted: Sep 6, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• 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, Superintendent, Show Chwan Memorial Hospital: Platelet-rich plasma; Osteoarthritis Knee
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Sep 6, 2019