Osteoarthritis (OA) of the Knee
Conditions
Brief summary
This study will focus on grade I to III knee osteoarthritis by randomized controlled trials which comparing the effectiveness between placebo, autologous platelet rich plasma and autologous platelet lysate injections.
Detailed description
The current methods for treating knee osteoarthritis include delaying the disease progression and joint replacement surgery. The usual treatment methods are mostly temporary, such as taking drug and hyaluronic acid injection. Therefore, finding the safe and effective methods will greatly reduce medical resource, medical expenses and surgery cost, etc., and restore the patient's quality of life. Platelet lysate is the product of complete activation from autologous platelet. It contains rich growth factors and cytokines such as PDGF, TGF-β, VEGF, EGF and IGF, etc. It can support cell growth and doesn't have any white blood cells in it. It is superior to the platelet rich plasma because of reducing the overall inflammatory response and pain of the patient during treatment.
Interventions
OTHERSaline injection
5ml Placebo infusion of 0.9% Sodium Chloride
BIOLOGICALPRP injection
Device: Aeon Acti-PRP 5ml autologous platelet rich plasma injection
BIOLOGICALPL injection
Device: Aeon Acti-PRP 5ml autologous platelet lysate injection
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 50 to 80 years old * Study Subjects must be willing to sign Informed Consent to participate in the study * In the past month, at least seven consecutive days in the squat, standing, walking or going up and down the stairs, the most serious degree of visual analogy of the knee pain (Visual Analogue Scale) is greater than or equal to 40 (the most pain is 100, not painful is 0) * Morning joint stiffness is less than 30 minutes * X-ray：Grade 1-3 radiographic OA as defined by the K-L classification
Exclusion criteria
* Knee instability * The knee joint is obviously deformed (\> 5 degree valgus or varus deviation on X-ray) * Clinical diagnosed as Pes tendinitis, Chondromalacia * Taking NSAIDs or steroids (including oral and injection) within one week * Using anticoagulant drugs for a long time * Platelet count is less than 150,000 / UL, or coagulation disorders, prothrombin time (PT value) is less than 11 seconds or greater than 16 seconds * Leukemia, sepsis, platelet dysfunction or other blood related diseases * tumors, infections or the trauma before the same site * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score of the patient | up to 24 weeks after surgery | Using Visual Analog Score (from 0 to 10, 0 indicate no pain and 10 indicate maximal pain) to evaluate pain of surgical wound of the patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee functional score | up to 24 weeks after surgery | Using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
| X-ray | up to 24 weeks after surgery | Knee X-ray image |
| Ultrasonic image | up to 24 weeks after surgery | Ultrasonic-between thickness of the medial and lateral sides of the femoral condyle |
| adverse events | up to 24 weeks after surgery | adverse events in clinical trial |
Countries
Taiwan
Contacts
Primary ContactWU Chueh-Hung, MD, CIPS
Backup ContactWang Tyng-Guey, MD
Outcome results
None listed