Knee OsteoarthritisPhase 3NCT04972383
Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Knee Osteoarthritis
A Phase 3 study testing Platelet Rich Plasma and Hyaluronic Acid in people with Knee Osteoarthritis, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
To compare the efficacy and structural change of intraarticular single platelet-rich plasma(PRP) versus novel crosslinked Hyaluronic Acid(HA)(HyajointPlus) for the treatment of early stage knee osteoarthritis(OA). This was a prospective, double-blind, RCT with an allocation ratio of 1:1. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Platelet Rich Plasma and Hyaluronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Nov 2017to 16 Oct 2019
- Phase
- Phase 3
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients older than 50 years
- a diagnosis of primary knee osteoarthritis
- Kellgren-Lawrence (K-L) grading scale smaller than 3
- both male and female.
Who cannot join
- patients younger than 50 years of age
- K-L grade 3 or more
- history or active presence of clinically significant inflammatory articular or rheumatic disease other than OA
- generalized OA
- the detection of rapidly progressive OA before the start of the trial
- underwent any previous lower extremity surgery
Show all 16Show fewer
- excessive mechanical axis deviation (varus > 5°, valgus > 5°)
- body mass index larger than 30
- history or presence of malignant disorders
- systemic disorders such as diabetes mellitus, severe cardiovascular diseases, hematologic diseases, immune-deficiencies, and infections
- systematic or intra-articular corticosteroid therapy in the previous 3 months
- prior treatment with HA in the past 6 months
- anticoagulants or antiaggregants therapy in the preceding 30 days
- non-steroidal anti-inflammatory medications in the preceding 7 days
- platelet count less than 150,000/ml of blood
- hemoglobin values less than 12g/dL of blood.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective,Double-Blind Randomized Controlled Trial Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Progression of Structural Changes in Knee Osteoarthritis
To compare the efficacy and structural change of intraarticular single platelet-rich plasma(PRP) versus novel crosslinked Hyaluronic Acid(HA)(HyajointPlus) for the treatment of early stage knee osteoarthritis(OA). This was a prospective, double-blind, RCT with an allocation ratio of 1:1.
Read the detailed description
In the PRP group, an Aeon Acti-PRP set was used and an approximately 4-mL PRP volume was yielded and was used in a single-dose treatment. In the HA group, HYAJOINT Plus containing 60 mg of purified sodium hyaluronate was used in a single-dose treatment. All PRP and HA injection syringes were covered with opaque envelop, and the intra-articular injection procedure was performed by the same physician without ultrasound or other imaging guidance.
- Conditions
- Knee Osteoarthritis
- Being tested
- Platelet Rich Plasma, Hyaluronic Acid
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaCombination product
In the Platelet Rich Plasma group, 4mL Platelet Rich Plasma was given.
Hyaluronic AcidCombination product
In the Hyaluronic group, 3mLHYAJOINT Plus was given.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma group | Experimental | single injection platelet rich plasma Receives: Combination Product: Platelet Rich Plasma |
| Hyaluronic Acid group | Experimental | single injection of hyaluronic acid Receives: Combination Product: Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Western Ontario and McMaster Universities Index (WOMAC) score from baseline
The minimum value of Western Ontario and McMaster Universities Index (WOMAC) score is zero and the maximum is 96, whether higher scores mean a worse outcome.
Measured: Baseline and 1-month, 3-month, 6-month after injection
Secondary outcomes (3)
The change of Knee Cartilage Grading System from baseline
The Cartilage Grading System classifies the cartilage from grades 0 to 6 according to parameters of sharpness, clarity and thickness change of the cartilage band. Grade 0 refers to normal and healthy cartilage, while grade 6 refers to severely eroded cartilage, whether higher scores mean a worse outcome.
Measured: Baseline and 1-month, 3-month, 6-month after injection
The change of Knee Cartilage strain ratio from baseline
The strain represents the elasticity. We used the overlying soft tissue as reference. Larger strain ratio means the cartilage is softer, while smaller strain ratio means the cartilage is harder.
Measured: Baseline and 1-month, 3-month, 6-month after injection
The change of MRI Osteoarthritis Knee Score (MOAKS) from baseline
Fourteen subregions are defined for scoring of articular cartilage and bone marrow lesions in cluding patella, femur and tibia region. Grade 0 refers to normal and healthy cartilage without loss, while grade 3 refers >75% cartilage full thickness loss, whether higher scores mean a worse outcome.
Measured: Baseline and 6-month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start7 Nov 2017
- Primary completion16 Oct 2019
- Study completion16 Oct 2019
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 Kaohsiung Medical University Chung-Ho Memorial 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsuan-Ti Huang, M.D, Study chair, Kaohsiung Medical University, Orthopedics Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972383
- Sponsor's protocol ID
- KMUHIRB-F(II)-20170062
- Status last verified
- Jun 2021
- First submitted
- 6 Jul 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Double-Blind Randomized Controlled Trial Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Progression of Structural Changes in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04972383
- Acronym / sponsor ID
- KMUHIRB-F(II)-20170062
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 22 Jul 2021 (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.
To compare the efficacy and structural change of intraarticular single platelet-rich plasma(PRP) versus novel crosslinked Hyaluronic Acid(HA)(HyajointPlus) for the treatment of early stage knee osteoarthritis(OA). This was a prospective, double-blind, RCT with an allocation ratio of 1:1.
Detailed description
In the PRP group, an Aeon Acti-PRP set was used and an approximately 4-mL PRP volume was yielded and was used in a single-dose treatment. In the HA group, HYAJOINT Plus containing 60 mg of purified sodium hyaluronate was used in a single-dose treatment. All PRP and HA injection syringes were covered with opaque envelop, and the intra-articular injection procedure was performed by the same physician without ultrasound or other imaging guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma group | Experimental | Combination Product: Platelet Rich Plasmasingle injection platelet rich plasma |
| Hyaluronic Acid group | Experimental | Combination Product: Hyaluronic Acidsingle injection of hyaluronic acid |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients older than 50 years
- a diagnosis of primary knee osteoarthritis
- Kellgren-Lawrence (K-L) grading scale smaller than 3
- both male and female.
Key exclusion criteria (16 listed)
- patients younger than 50 years of age
- K-L grade 3 or more
- history or active presence of clinically significant inflammatory articular or rheumatic disease other than OA
- generalized OA
- the detection of rapidly progressive OA before the start of the trial
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 |
|---|---|---|
| Platelet Rich PlasmaIn the Platelet Rich Plasma group, 4mL Platelet Rich Plasma was given. | Combination product | Platelet Rich Plasma group |
| Hyaluronic AcidIn the Hyaluronic group, 3mLHYAJOINT Plus was given. | Combination product | Hyaluronic Acid group |
Primary outcome
The change of Western Ontario and McMaster Universities Index (WOMAC) score from baseline
Time frame: Baseline and 1-month, 3-month, 6-month after injection
The minimum value of Western Ontario and McMaster Universities Index (WOMAC) score is zero and the maximum is 96, whether higher scores mean a worse outcome.
3 secondary outcomes
The change of Knee Cartilage Grading System from baseline
Time frame: Baseline and 1-month, 3-month, 6-month after injection
The change of Knee Cartilage strain ratio from baseline
Time frame: Baseline and 1-month, 3-month, 6-month after injection
The change of MRI Osteoarthritis Knee Score (MOAKS) from baseline
Time frame: Baseline and 6-month after injection
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 10 Oct 2023.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Knee Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Hsuan-Ti Huang, M.D study chair
Kaohsiung Medical University, Orthopedics Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet Rich Plasma and Hyaluronic Acid in people with Knee Osteoarthritis, run by Kaohsiung Medical University Chung-Ho Memorial 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 4 inclusion and 16 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 10 Oct 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The change of Western Ontario and McMaster Universities Index (WOMAC) score from baseline (time frame: Baseline and 1-month, 3-month, 6-month after injection). 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 10 Oct 2023.