Osteo Arthritis Knee Clinical Trial
Official title:
Intraoperative Platelet Rich Plasma Injection in Arthroscopic Surgery for Osteoarthritis of the Knee
Verified date | September 2019 |
Source | Show Chwan Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | June 28, 2018 |
Est. primary completion date | June 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Show Chwan Memorial Hospital | Changhua City | Changhua |
Lead Sponsor | Collaborator |
---|---|
Pei-Yuan Lee, MD | Aeon Biotechnology Corporation |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in knee function from baseline to postoperative 3 months | Knee function is evaluated using Oswestry Disability Index preoperatively and 3-month postoperatively. | 3-month postoperative | |
Secondary | Change in knee function from baseline to postoperative 6 months | Knee function is evaluated using Oswestry Disability Index preoperatively and 6-month postoperatively. | 6-month postoperative | |
Secondary | Change in knee function from baseline to postoperative 12 months | Knee function is evaluated using Oswestry Disability Index preoperatively and 12-month postoperatively. | 12-month postoperative | |
Secondary | Change in knee pain from baseline to postoperative 3 months | Pain is evaluated using visual analogue scale preoperatively and 3-month postoperatively. | 3-month postoperative | |
Secondary | Change in knee pain from baseline to postoperative 6 months | Pain is evaluated using visual analogue scale preoperatively and 6-month postoperatively. | 6-month postoperative | |
Secondary | Change in knee pain from baseline to postoperative 12 months | Pain is evaluated using visual analogue scale preoperatively and 12-month postoperatively. | 12-month postoperative | |
Secondary | Percentage of patients with regenerated cartilage | Cartilage regeneration is assessed by pathological biopsy during second look surgery at 12-month postoperative. | 12-month postoperative | |
Secondary | Change in cartilage thickness from baseline to postoperative 6 months | Cartilage thickness is assessed by MRI preoperatively and 6-month postoperatively. | 6-month postoperative |
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