Osteoarthritis (OA) of the KneePhase 4NCT03734900
Comparison of Effectiveness Between PL and PRP on Knee Osteoarthritis: a Prospective,Randomized,Placebo-controlled Trial
A Phase 4 study testing Saline injection, PRP injection and PL injection in people with Osteoarthritis (OA) of the Knee, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- Saline injection, PRP injection and PL injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 May 2018to 14 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Leukemia, sepsis, platelet dysfunction or other blood related diseases
- tumors, infections or the trauma before the same site
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Wu Chueh-hung, MD,CIPS, 0223123456 ext. 66473, nojred@gmail.com
About this study
Official title: Comparison of Effectiveness Between Platelet Lysate and Platelet-rich Plasma on Knee Osteoarthritis: a Prospective, Randomized, Placebo-controlled Trial
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.
Read the 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.
- Conditions
- Osteoarthritis (OA) of the Knee
- Being tested
- Saline injection, PRP injection, PL injection
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline injectionOther
5ml Placebo infusion of 0.9% Sodium Chloride
PRP injectionBiological
Device: "Aeon" Acti-PRP
5ml autologous platelet rich plasma injection
PL injectionBiological
Device: "Aeon" Acti-PRP
5ml autologous platelet lysate injection
| Study group | Role | What they receive |
|---|---|---|
| Saline injection | Placebo comparator | Sodium Chloride injection into the study knee joint every 4 weeks for a total of 3 injections Receives: Other: Saline injection |
| PRP injection | Experimental | PRP injection into the study knee joint every 4 weeks for a total of 3 injections Receives: Biological: PRP injection |
| PL injection | Experimental | PL injection into the study knee joint every 4 weeks for a total of 3 injections Platelet lysate is the product of nature activation from autologous platelet. Receives: Biological: PL injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score of the patient
Using Visual Analog Score (from 0 to 10, 0 indicate no pain and 10 indicate maximal pain) to evaluate pain of surgical wound of the patient
Measured: up to 24 weeks after surgery
Secondary outcomes (4)
Knee functional score
Using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: up to 24 weeks after surgery
X-ray
Knee X-ray image
Measured: up to 24 weeks after surgery
Ultrasonic image
Ultrasonic-between thickness of the medial and lateral sides of the femoral condyle
Measured: up to 24 weeks after surgery
adverse events
adverse events in clinical trial
Measured: up to 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start15 May 2018
- Primary completion14 May 2027 (estimated)
- Study completion14 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wu Chueh-Hung, MD, CIPS, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734900
- Sponsor's protocol ID
- 201803124RIPD
- Status last verified
- Jun 2026
- First submitted
- 25 Oct 2018
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness Between Platelet Lysate and Platelet-rich Plasma on Knee Osteoarthritis: a Prospective, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03734900
- Acronym / sponsor ID
- 201803124RIPD
- Conditions
- Osteoarthritis (OA) of the Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 14 May 2027 (estimated)
- Study completion
- 14 May 2027 (estimated)
- First posted
- 8 Nov 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saline injection | Placebo comparator | Other: Saline injectionSodium Chloride injection into the study knee joint every 4 weeks for a total of 3 injections |
| PRP injection | Experimental | Biological: PRP injectionPRP injection into the study knee joint every 4 weeks for a total of 3 injections |
| PL injection | Experimental | Biological: PL injectionPL injection into the study knee joint every 4 weeks for a total of 3 injections Platelet lysate is the product of nature activation from autologous platelet. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Saline injection5ml Placebo infusion of 0.9% Sodium Chloride | Other | Saline injection |
| PRP injectionDevice: "Aeon" Acti-PRP 5ml autologous platelet rich plasma injection | Biological | PRP injection |
| PL injectionDevice: "Aeon" Acti-PRP 5ml autologous platelet lysate injection | Biological | PL injection |
Primary outcome
Pain score of the patient
Time frame: up to 24 weeks after surgery
Using Visual Analog Score (from 0 to 10, 0 indicate no pain and 10 indicate maximal pain) to evaluate pain of surgical wound of the patient
4 secondary outcomes
Knee functional score
Time frame: up to 24 weeks after surgery
X-ray
Time frame: up to 24 weeks after surgery
Ultrasonic image
Time frame: up to 24 weeks after surgery
adverse events
Time frame: up to 24 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 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.
Wu Chueh-Hung, MD, CIPS study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saline injection, PRP injection and PL injection in people with Osteoarthritis (OA) of the Knee, run by National Taiwan University 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 21 Sep 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WU Chueh-Hung, MD, CIPS (0223123456 ext. 66473, nojred@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score of the patient (time frame: up to 24 weeks after surgery). 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 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.