Clinical trial NCT03734900: Comparison of Effectiveness Between PL and PRP on Knee Osteoarthritis: a Prospective,Randomized,Placebo-controlled Trial
Official title: Comparison of Effectiveness Between Platelet Lysate and Platelet-rich Plasma on Knee Osteoarthritis: a Prospective, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis (OA) of the Knee
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score of the patient
timeFrame: up to 24 weeks after surgery
Secondary outcomes:
measure: Knee functional score
timeFrame: up to 24 weeks after surgery
measure: X-ray
timeFrame: up to 24 weeks after surgery
measure: Ultrasonic image
timeFrame: up to 24 weeks after surgery
measure: adverse events
timeFrame: up to 24 weeks after surgery
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Wu Chueh-Hung, MD, CIPS
role: STUDY_DIRECTOR
References: