- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03290365
The Combination Effect of Platelet-rich Plasma and Hyaluronic Acid for Knee Osteoarthritis
July 10, 2021 updated by: Yung-Tsan Wu, Tri-Service General Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Neihu District
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Taipei, Neihu District, Taiwan, 886
- Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Platelet rich plasma + Hyaluronic acid
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.
|
Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee.
|
Placebo Comparator: Platelet rich plasma + normal saline
Patients received one dose of PRP injection.
One week later, the one dose of normal saline is injected for control group.
|
The normal salin as the placebo intervention was injection control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 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.
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Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
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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.
|
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).
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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.
|
Using the balance test (Biodex) to measure the balance function before treatment and multiple time frame after treatment.
|
Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
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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.
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The synovial fluid is aspirated to measure the parameters before treatment and multiple time frame after treatment.
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Pre-treatment, 6th month and one year after injection.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yung-Tsan Wu, MD, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Lana 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.
- Chen 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.
- Dallari 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2018
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
September 19, 2017
First Submitted That Met QC Criteria
September 19, 2017
First Posted (Actual)
September 21, 2017
Study Record Updates
Last Update Posted (Actual)
July 13, 2021
Last Update Submitted That Met QC Criteria
July 10, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRP and HA for OA knee
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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