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The Combination Effect of Platelet-rich Plasma and Hyaluronic Acid for Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03290365
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Yung-Tsan Wu, Tri-Service General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: platelet rich plasma + Hyaluronic acid Drug: platelet rich plasma + normal saline Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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.
Drug: platelet rich plasma + Hyaluronic acid
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.
Drug: platelet rich plasma + normal saline
The normal salin as the placebo intervention was injection control group.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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. ]
    The synovial fluid is aspirated to measure the parameters before treatment and multiple time frame after treatment.



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 50 to 75 y/o.
  2. Alert consciousness
  3. Symptom of knee osteoarthritis persist at least 6 months and stage I to III scored by Ahlbäck grading system
  4. The pain score measured by VAS at least 4 points

Exclusion Criteria:

  1. Has received hyaluronic acid, PRP or steroid injection within 6 months
  2. Has received NSAIDs or steroid within one week
  3. Tumor or metastasis surrounding the knee joint
  4. Has received total knee replacement, major surgery in knee, rheumatoid arthritis
  5. Patient who cant tolerance the balance test.
  6. Thrombocytopenia or coagulopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290365


Contacts
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Contact: Yung-Tsan Wu, MD +886-2-8792-3311 ext 17068 crwu98@gmail.com

Locations
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Taiwan
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital Recruiting
Taipei, Neihu District, Taiwan, 886
Contact: Yung-Tsan Wu, MD    886-2-8792-3311 ext 17068    crwu98@gmail.com   
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
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Principal Investigator: Yung-Tsan Wu, MD Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center
Publications of Results:
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Responsible Party: Yung-Tsan Wu, Attending Physician, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT03290365    
Other Study ID Numbers: PRP and HA for OA knee
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yung-Tsan Wu, Tri-Service General Hospital:
Platelet rich plasma
Osteoarthritis of knee
Hyaluronic acid
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents