A Phase 2 interventional study of Lyophilized Platelet-rich Plasma Lysate and Dextrose Prolotherapy in Knee Osteoarthritis and Platelet-rich Plasma (PRP), sponsored by Taichung Veterans General Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Taichung Veterans General Hospital · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to compare the therapeutic effects of lyophilized platelet-rich plasma lysate and dextrose prolotherapy in patients with knee osteoarthritis (OA). The main questions it aims to answer are:
Researchers will compare patients receiving lyophilized platelet-rich plasma lysate with those receiving dextrose prolotherapy to evaluate differences in treatment effectiveness.
Participants will:
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's enrollment of 39 is below the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Taichung Veterans General Hospital is the lead sponsor of 175 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Patients older than 20 years of age.
Patients who are willing to provide written informed consent.
Exclusion Criteria:
Thrombocytopenia.
Hypofibrinogenemia.
Hemodynamic instability.
Sepsis.
Acute or chronic infectious diseases.
History of chronic liver disease.
Current anticoagulant therapy.
Long-term or excessive use of aspirin or vitamin E.
History of HIV infection, syphilis, or other legally notifiable infectious diseases.
Cognitive impairment that prevents compliance with study procedures or medical instructions.
Biological: Lyophilized Platelet-rich Plasma Lysate
Drug: Dextrose Prolotherapy
Lyophilized platelet-rich plasma lysate is an autologous platelet-derived preparation obtained from participants' peripheral blood. Approximately 130 mL of blood will be collected and processed using multiple centrifugation steps to isolate and concentrate platelets. The platelets will then be activated and lysed to release growth factors and other bioactive components, followed by lyophilization to produce a freeze-dried preparation. After sterility testing, participants in the intervention group will receive intra-articular injections of PRP Plus into the affected knee once monthly for three consecutive months, for a total of three injections.
Dextrose prolotherapy is an injection-based treatment using a hypertonic dextrose solution. Participants assigned to the control group will receive dextrose injections into the affected knee as an active comparator to lyophilized platelet-rich plasma lysate. The treatment aims to alleviate knee pain and improve joint function in patients with knee osteoarthritis. Participants will receive intra-articular injections once monthly for three consecutive months, for a total of three injections.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score from Baseline
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a patient-reported questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. It consists of 24 items across three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Each item is scored on a 5-point Likert scale ranging from 0 (none) to 4 (extreme), resulting in a total score ranging from 0 to 96. Higher scores indicate greater symptom severity and functional impairment. WOMAC scores will be assessed at baseline and one month after the third treatment. Changes in WOMAC scores from baseline will be compared between the two treatment groups to evaluate therapeutic efficacy.
Time frame: Baseline and 1 month after the third treatment
Change in Isokinetic Knee Muscle Strength
Isokinetic knee muscle strength will be assessed using a Biodex dynamometer at angular velocities of 60°/s and 120°/s. Peak torque (Nm) will be measured during knee extension and flexion at both velocities. Changes in muscle strength from baseline to one month after the third treatment session will be evaluated.
Time frame: From baseline to one month after the third treatment session.
Change in Kellgren-Lawrence (KL) Grade
Radiographic severity of knee osteoarthritis will be evaluated using the Kellgren-Lawrence (KL) grading system, ranging from grade 0 (no osteoarthritis) to grade 4 (severe osteoarthritis). Changes in KL grade from baseline to one month after the third treatment session will be assessed.
Time frame: From baseline to one month after the third treatment session.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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