Skip to main content
OpenTrials
Completed

NCT Number: NCT03290365

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, 886, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

platelet rich plasma + Hyaluronic acid

Drug

Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee.

platelet rich plasma + normal saline

Drug

The normal salin as the placebo intervention was injection control group.

Primary outcomes

  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 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.

Secondary outcomes

  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. A higher score indicate more severe.

  2. 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).

  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.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 21, 2017
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.