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

  • Taiwan
    • Neihu District
      • Taipei, Neihu District, Taiwan, 886
        • Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

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:

  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

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.
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.

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.
Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.

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.
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.
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).
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.
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.
Pre-treatment, 6th month and one year after injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

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

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

Keywords

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.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on platelet rich plasma + Hyaluronic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe