Osteo Arthritis Knee, Platelet-rich Plasma
Conditions
Keywords
Platelet-rich plasma, Osteoarthritis Knee
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.
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.
Interventions
OTHERPlatelet-rich plasma
Intraoperative platelet-rich plasma injection during arthroscopic knee surgery
Sponsors
Aeon Biotechnology Corporation
Pei-Yuan Lee, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 function from baseline to postoperative 6 months | 6-month postoperative | Knee function is evaluated using Oswestry Disability Index preoperatively and 6-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. |
| 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. |
Countries
Taiwan
Outcome results
None listed