JPRN-jRCTb032190218
Completed
Phase 2
Intra-articular injections of platelet-rich plasma for the treatment of osteoarthritis of the knee: a randomized, double-blind, placebo-controlled phase 2 clinical trial. - PRP treatment for osteoarthritis of the knee.
Yamazaki Masashi0 sites30 target enrollmentFebruary 19, 2020
Conditionsosteoarthritis of the knee
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- osteoarthritis of the knee
- Sponsor
- Yamazaki Masashi
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who meet the diagnostic criteria for osteoarthritis of the knee
- •2\. Male and female between 20 years old more and less than 80 years old at the time of informed consent
- •3\. With a history of chronic (for at least 3 months) knee joint pain more than 35\-mm on 0\- to 100\-mm visual analogue scale
- •4\. Radiographically documented grades 1\-3 osteoarthritis of the knee, grade according to the Kellgren\-Lawrence radiographic classification scale
- •5\. With hydrarthrosis or bone marrow lesion or synovitis
- •6\. Requiring infiltration in monolateral knee
- •7\. Possibility for observation during follow\-up period of 24 weeks
Exclusion Criteria
- •1\. BMI less than 18\.5
- •2\. BMI more than 30
- •3\. Suffering from polyarticular disease
- •4\. Valgus knee and varus knee more than 10 degree in X\-ray
- •5\. Previous knee arthroscopy within 6 months
- •6\. HA or steroid intra\-articular infiltration within last 1 month
- •7\. Past history of infectious disease
- •8\. Skin disease in knee
- •9\. Compromised host
- •10\. Systemic autoimmune disease
Outcomes
Primary Outcomes
Not specified
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