Knee OsteoarthritisPhase 2NCT07875543
Comparison of the Therapeutic Effects of Lyophilized Platelet-rich Plasma Lysate and Dextrose Prolotherapy in Knee Osteoarthritis
A Phase 2 study testing Lyophilized Platelet-rich Plasma Lysate and Dextrose Prolotherapy in people with Knee Osteoarthritis and Platelet-rich Plasma (PRP), run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Knee Osteoarthritis, Platelet-rich Plasma (PRP)
- What is being tested?
- Lyophilized Platelet-rich Plasma Lysate and Dextrose Prolotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2024to 22 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Platelet dysfunction.
- Thrombocytopenia.
- Hypofibrinogenemia.
- Hemodynamic instability.
- Sepsis.
- Acute or chronic infectious diseases.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Therapeutic Effects of Lyophilized Platelet-Rich Plasma Lysate and Dextrose Prolotherapy in Knee Osteoarthritis
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?
Read more
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)
- Being tested
- Lyophilized Platelet-rich Plasma Lysate, Dextrose Prolotherapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyophilized Platelet-rich Plasma LysateBiological
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 ProlotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Lyophilized Platelet-rich Plasma Lysate | Experimental | Not described Receives: Biological: Lyophilized Platelet-rich Plasma Lysate |
| Dextrose Prolotherapy | Active comparator | Not described Receives: Drug: Dextrose Prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 month after the third treatment
Secondary outcomes (2)
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.
Measured: 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.
Measured: From baseline to one month after the third treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Jan 2024
- Primary completion22 Jul 2026
- Study completion22 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875543
- Sponsor's protocol ID
- reh56789
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Therapeutic Effects of Lyophilized Platelet-Rich Plasma Lysate and Dextrose Prolotherapy in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07875543
- Acronym / sponsor ID
- reh56789
- Conditions
- Knee Osteoarthritis, Platelet-rich Plasma (PRP)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 22 Jul 2026 (actual)
- Study completion
- 22 Jul 2026 (actual)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lyophilized Platelet-rich Plasma Lysate | Experimental | Biological: Lyophilized Platelet-rich Plasma Lysate |
| Dextrose Prolotherapy | Active comparator | Drug: Dextrose Prolotherapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- Platelet dysfunction.
- Thrombocytopenia.
- Hypofibrinogenemia.
- Hemodynamic instability.
- Sepsis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lyophilized Platelet-rich Plasma LysateLyophilized 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. | Biological | Lyophilized Platelet-rich Plasma Lysate |
| Dextrose ProlotherapyDextrose 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. | Drug | Dextrose Prolotherapy |
Primary outcome
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score from Baseline
Time frame: Baseline and 1 month after the third treatment
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.
2 secondary outcomes
Change in Isokinetic Knee Muscle Strength
Time frame: From baseline to one month after the third treatment session.
Change in Kellgren-Lawrence (KL) Grade
Time frame: From baseline to one month after the third treatment session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lyophilized Platelet-rich Plasma Lysate and Dextrose Prolotherapy in people with Knee Osteoarthritis and Platelet-rich Plasma (PRP), run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score from Baseline (time frame: Baseline and 1 month after the third treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.