Comparison of the Therapeutic Effects of Lyophilized Platelet-rich Plasma Lysate and Dextrose Prolotherapy in Knee Osteoarthritis

NCT07875543 | Completed Phase 2 DMC

• 1 other identifier: reh56789
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Does lyophilized platelet-rich plasma lysate improve pain, physical function, and muscle strength in patients with knee osteoarthritis?
• Is lyophilized platelet-rich plasma lysate more effective than dextrose prolotherapy in improving clinical outcomes in patients with knee osteoarthritis? Researchers will compare patients receiving lyophilized platelet-rich plasma lysate with those receiving dextrose prolotherapy to evaluate differences in treatment effectiveness. Participants will:
• Receive intra-articular injections of either lyophilized platelet-rich plasma lysate or dextrose prolotherapy.
• Undergo clinical assessments before and after treatment, including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to evaluate pain, stiffness, and physical function.
• Undergo knee X-ray examinations to assess osteoarthritis severity using the Kellgren-Lawrence (KL) grading system.
• Undergo isokinetic muscle strength testing using a Biodex dynamometer to evaluate knee muscle strength.

Conditions

Knee Osteoarthritis; Platelet-rich Plasma (PRP)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 1 month after the third treatment

Secondary Outcomes (2)

• Change in Isokinetic Knee Muscle Strength

  From baseline to one month after the third treatment session.

• Change in Kellgren-Lawrence (KL) Grade

  From baseline to one month after the third treatment session.

Study Arms (2)

Lyophilized Platelet-rich Plasma Lysate

EXPERIMENTAL

Biological: Lyophilized Platelet-rich Plasma Lysate

Dextrose Prolotherapy

ACTIVE COMPARATOR

Drug: Dextrose Prolotherapy

Interventions

Lyophilized Platelet-rich Plasma Lysate BIOLOGICAL

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.

Lyophilized Platelet-rich Plasma Lysate

Dextrose Prolotherapy DRUG

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.

Dextrose Prolotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with radiographically confirmed knee osteoarthritis of Kellgren-Lawrence grade III or lower.
• Patients older than 20 years of age.
• Patients who are willing to provide written informed consent.

You may not qualify if:

• Platelet dysfunction.
• 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.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 15, 2026
• Study Start: January 1, 2024
• Primary Completion: July 22, 2026
• Study Completion: July 22, 2026
• Last Updated: October 15, 2026

Record last verified: 2026-10

Locations

TW (1)