Knee OsteoarthritisNCT03290365
The Combination Effect of Platelet-rich Plasma and Hyaluronic Acid for Knee Osteoarthritis
A study testing platelet rich plasma + Hyaluronic acid and platelet rich plasma + normal saline in people with Knee Osteoarthritis, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
Although platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for osteoarthritis of knee (OA knee), the combined effect of PRP with HA was not clear so far. Hence, investigator assess a prospective randomized double-blind controlled trial. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- platelet rich plasma + Hyaluronic acid and platelet rich plasma + normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jan 2018to 1 Jul 2021
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50 to 75 y/o.
- Alert consciousness
- Symptom of knee osteoarthritis persist at least 6 months and stage I to III scored by Ahlbäck grading system
- The pain score measured by VAS at least 4 points
Who cannot join
- Has received hyaluronic acid, PRP or steroid injection within 6 months
- Has received NSAIDs or steroid within one week
- Tumor or metastasis surrounding the knee joint
- Has received total knee replacement, major surgery in knee, rheumatoid arthritis
- Patient who cant tolerance the balance test.
- Thrombocytopenia or coagulopathy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, 886
About this study
Official title: The Combination Long-term Effect of Platelet-rich Plasma and Hyaluronic Acid in Patients With Knee Osteoarthritis: a Prospective Randomized Double-blind Controlled Trial
Although platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for osteoarthritis of knee (OA knee), the combined effect of PRP with HA was not clear so far. Hence, investigator assess a prospective randomized double-blind controlled trial.
Read the detailed description
Patients with single or bilateral OA knee will be enrolled and randomized into intervention and control group. One dose of PRP is applied into both groups. One week later, one dose of HA is injected in intervention group and one dose of normal saline is injected in control group. Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and analysis of synovial fluid at different follow-up frame (1st month, 3rd month, 6th month and 1 year after treatment).
- Conditions
- Knee Osteoarthritis
- Being tested
- platelet rich plasma + Hyaluronic acid, platelet rich plasma + normal saline
- Keywords
- Platelet rich plasma, Osteoarthritis of knee, 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 plasma + Hyaluronic acidDrug
Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee.
platelet rich plasma + normal salineDrug
The normal salin as the placebo intervention was injection control group.
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasma + Hyaluronic acid | Active comparator | Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee. Patients received one dose of PRP injection. One week later, the one dose of HA is injected for intervention group. Receives: Drug: platelet rich plasma + Hyaluronic acid |
| Platelet rich plasma + normal saline | Placebo comparator | Patients received one dose of PRP injection. One week later, the one dose of normal saline is injected for control group. Receives: Drug: platelet rich plasma + normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection.
Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to measure the symptoms and functional status before treatment and multiple time frame after treatment. Both subscales has the scores ranged from 1 to 5 for each item and a higher score indicating more severe of symptom or impaired functional status.
Measured: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
Secondary outcomes (4)
Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection.
Using the Lequesne's severity index to measure the symptoms and functional status before treatment and multiple time frame after treatment. A higher score indicate more severe.
Measured: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
Change from baseline of pain on 1st month, 3rd month, 6th month and one year after injection.
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. The score ranging from 10 (remarkable pain) to 0 (no pain).
Measured: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
Change from baseline in balance function on 1st month, 3rd month, 6th month and one year after injection.
Using the balance test (Biodex) to measure the balance function before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
Change from baseline in analysis of synovial fluid on 6th month and one year after injection.
The synovial fluid is aspirated to measure the parameters before treatment and multiple time frame after treatment.
Measured: Pre-treatment, 6th month and one year after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start10 Jan 2018
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yung-Tsan Wu, Tri-Service General Hospital (TSGH)
- Investigators
- Yung-Tsan Wu, MD, Principal investigator, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290365
- Sponsor's protocol ID
- PRP and HA for OA knee
- Status last verified
- Jul 2021
- First submitted
- 19 Sep 2017
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abate M, Verna S, Schiavone C, Di Gregorio P, Salini V. Efficacy and safety profile of a compound composed of platelet-rich plasma and hyaluronic acid in the treatment for knee osteoarthritis (preliminary results). Eur J Orthop Surg Traumatol. 2015 Dec;25(8):1321-6. doi: 10.1007/s00590-015-1693-3. Epub 2015 Sep 24.
PubMed 26403468Lana JF, Weglein A, Sampson SE, Vicente EF, Huber SC, Souza CV, Ambach MA, Vincent H, Urban-Paffaro A, Onodera CM, Annichino-Bizzacchi JM, Santana MH, Belangero WD. Randomized controlled trial comparing hyaluronic acid, platelet-rich plasma and the combination of both in the treatment of mild and moderate osteoarthritis of the knee. J Stem Cells Regen Med. 2016 Nov 29;12(2):69-78. doi: 10.46582/jsrm.1202011. eCollection 2016.
PubMed 28096631Chen SH, Kuan TS, Kao MJ, Wu WT, Chou LW. Clinical effectiveness in severe knee osteoarthritis after intra-articular platelet-rich plasma therapy in association with hyaluronic acid injection: three case reports. Clin Interv Aging. 2016 Sep 8;11:1213-1219. doi: 10.2147/CIA.S114795. eCollection 2016.
PubMed 27660427Dallari D, Stagni C, Rani N, Sabbioni G, Pelotti P, Torricelli P, Tschon M, Giavaresi G. Ultrasound-Guided Injection of Platelet-Rich Plasma and Hyaluronic Acid, Separately and in Combination, for Hip Osteoarthritis: A Randomized Controlled Study. Am J Sports Med. 2016 Mar;44(3):664-71. doi: 10.1177/0363546515620383. Epub 2016 Jan 21.
PubMed 26797697
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination Long-term Effect of Platelet-rich Plasma and Hyaluronic Acid in Patients With Knee Osteoarthritis: a Prospective Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT03290365
- Acronym / sponsor ID
- PRP and HA for OA knee
- Conditions
- Knee Osteoarthritis
- Keywords
- Platelet rich plasma, Osteoarthritis of knee, Hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 21 Sep 2017 (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.
Although platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for osteoarthritis of knee (OA knee), the combined effect of PRP with HA was not clear so far. Hence, investigator assess a prospective randomized double-blind controlled trial.
Detailed description
Patients with single or bilateral OA knee will be enrolled and randomized into intervention and control group. One dose of PRP is applied into both groups. One week later, one dose of HA is injected in intervention group and one dose of normal saline is injected in control group. Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and analysis of synovial fluid at different follow-up frame (1st month, 3rd month, 6th month and 1 year after treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasma + Hyaluronic acid | Active comparator | Drug: platelet rich plasma + Hyaluronic acidPlatelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee. Patients received one dose of PRP injection. One week later, the one dose of HA is injected for intervention group. |
| Platelet rich plasma + normal saline | Placebo comparator | Drug: platelet rich plasma + normal salinePatients received one dose of PRP injection. One week later, the one dose of normal saline is injected for control group. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 50 to 75 y/o.
- Alert consciousness
- Symptom of knee osteoarthritis persist at least 6 months and stage I to III scored by Ahlbäck grading system
- The pain score measured by VAS at least 4 points
Key exclusion criteria (6 listed)
- Has received hyaluronic acid, PRP or steroid injection within 6 months
- Has received NSAIDs or steroid within one week
- Tumor or metastasis surrounding the knee joint
- Has received total knee replacement, major surgery in knee, rheumatoid arthritis
- Patient who cant tolerance the balance test.
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 plasma + Hyaluronic acidPlatelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee. | Drug | Platelet rich plasma + Hyaluronic acid |
| platelet rich plasma + normal salineThe normal salin as the placebo intervention was injection control group. | Drug | Platelet rich plasma + normal saline |
Primary outcome
Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection.
Time frame: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to measure the symptoms and functional status before treatment and multiple time frame after treatment. Both subscales has the scores ranged from 1 to 5 for each item and a higher score indicating more severe of symptom or impaired functional status.
4 secondary outcomes
Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection.
Time frame: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
Change from baseline of pain on 1st month, 3rd month, 6th month and one year after injection.
Time frame: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
Change from baseline in balance function on 1st month, 3rd month, 6th month and one year after injection.
Time frame: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
Change from baseline in analysis of synovial fluid on 6th month and one year after injection.
Time frame: Pre-treatment, 6th month and one year 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 13 Jul 2021.
- Results publication: PubMed 26403468Abate M, Verna S, Schiavone C, Di Gregorio P, Salini V. Efficacy and safety profile of a compound composed of platelet-rich plasma and hyaluronic acid in the treatment for knee osteoarthritis (preliminary results). Eur J Orthop Surg Traumatol. 2015 Dec;25(8):1321-6. doi: 10.1007/s00590-015-1693-3. Epub 2015 Sep 24.
- Results publication: PubMed 28096631Lana JF, Weglein A, Sampson SE, Vicente EF, Huber SC, Souza CV, Ambach MA, Vincent H, Urban-Paffaro A, Onodera CM, Annichino-Bizzacchi JM, Santana MH, Belangero WD. Randomized controlled trial comparing hyaluronic acid, platelet-rich plasma and the combination of both in the treatment of mild and moderate osteoarthritis of the knee. J Stem Cells Regen Med. 2016 Nov 29;12(2):69-78. doi: 10.46582/jsrm.1202011. eCollection 2016.
- Results publication: PubMed 27660427Chen SH, Kuan TS, Kao MJ, Wu WT, Chou LW. Clinical effectiveness in severe knee osteoarthritis after intra-articular platelet-rich plasma therapy in association with hyaluronic acid injection: three case reports. Clin Interv Aging. 2016 Sep 8;11:1213-1219. doi: 10.2147/CIA.S114795. eCollection 2016.
- Results publication: PubMed 26797697Dallari D, Stagni C, Rani N, Sabbioni G, Pelotti P, Torricelli P, Tschon M, Giavaresi G. Ultrasound-Guided Injection of Platelet-Rich Plasma and Hyaluronic Acid, Separately and in Combination, for Hip Osteoarthritis: A Randomized Controlled Study. Am J Sports Med. 2016 Mar;44(3):664-71. doi: 10.1177/0363546515620383. Epub 2016 Jan 21.
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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.
Yung-Tsan Wu, MD principal investigator
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet rich plasma + Hyaluronic acid and platelet rich plasma + normal saline in people with Knee Osteoarthritis, run by Tri-Service General Hospital (TSGH) 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 6 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 13 Jul 2021. 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.
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 from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection. (time frame: Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03290365, which also lists 4 linked publications.
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 13 Jul 2021.