Skip to main content
OpenTrials
Completed

NCT Number: NCT04972383

Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Knee Osteoarthritis

To compare the efficacy and structural change of intraarticular single platelet-rich plasma(PRP) versus novel crosslinked Hyaluronic Acid(HA)(HyajointPlus) for the treatment of early stage knee osteoarthritis(OA). This was a prospective, double-blind, RCT with an allocation ratio of 1:1.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

About this study

In the PRP group, an Aeon Acti-PRP set was used and an approximately 4-mL PRP volume was yielded and was used in a single-dose treatment. In the HA group, HYAJOINT Plus containing 60 mg of purified sodium hyaluronate was used in a single-dose treatment. All PRP and HA injection syringes were covered with opaque envelop, and the intra-articular injection procedure was performed by the same physician without ultrasound or other imaging guidance.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients older than 50 years
  • a diagnosis of primary knee osteoarthritis
  • Kellgren-Lawrence (K-L) grading scale smaller than 3
  • both male and female.

Exclusion criteria

  • patients younger than 50 years of age
  • K-L grade 3 or more
  • history or active presence of clinically significant inflammatory articular or rheumatic disease other than OA
  • generalized OA
  • the detection of rapidly progressive OA before the start of the trial
  • underwent any previous lower extremity surgery
  • excessive mechanical axis deviation (varus > 5°, valgus > 5°)
  • body mass index larger than 30
  • history or presence of malignant disorders
  • systemic disorders such as diabetes mellitus, severe cardiovascular diseases, hematologic diseases, immune-deficiencies, and infections
  • systematic or intra-articular corticosteroid therapy in the previous 3 months
  • prior treatment with HA in the past 6 months
  • anticoagulants or antiaggregants therapy in the preceding 30 days
  • non-steroidal anti-inflammatory medications in the preceding 7 days
  • platelet count less than 150,000/ml of blood
  • hemoglobin values less than 12g/dL of blood.

Treatment and study plan

Platelet Rich Plasma

Combination Product

In the Platelet Rich Plasma group, 4mL Platelet Rich Plasma was given.

Hyaluronic Acid

Combination Product

In the Hyaluronic group, 3mLHYAJOINT Plus was given.

Primary outcomes

  1. The change of Western Ontario and McMaster Universities Index (WOMAC) score from baseline

    Time frame: Baseline and 1-month, 3-month, 6-month after injection

    The minimum value of Western Ontario and McMaster Universities Index (WOMAC) score is zero and the maximum is 96, whether higher scores mean a worse outcome.

Secondary outcomes

  1. The change of Knee Cartilage Grading System from baseline

    Time frame: Baseline and 1-month, 3-month, 6-month after injection

    The Cartilage Grading System classifies the cartilage from grades 0 to 6 according to parameters of sharpness, clarity and thickness change of the cartilage band. Grade 0 refers to normal and healthy cartilage, while grade 6 refers to severely eroded cartilage, whether higher scores mean a worse outcome.

  2. The change of Knee Cartilage strain ratio from baseline

    Time frame: Baseline and 1-month, 3-month, 6-month after injection

    The strain represents the elasticity. We used the overlying soft tissue as reference. Larger strain ratio means the cartilage is softer, while smaller strain ratio means the cartilage is harder.

  3. The change of MRI Osteoarthritis Knee Score (MOAKS) from baseline

    Time frame: Baseline and 6-month after injection

    Fourteen subregions are defined for scoring of articular cartilage and bone marrow lesions in cluding patella, femur and tibia region. Grade 0 refers to normal and healthy cartilage without loss, while grade 3 refers >75% cartilage full thickness loss, whether higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

A Prospective,Double-Blind Randomized Controlled Trial Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Progression of Structural Changes in Knee Osteoarthritis

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 22, 2021
Registry last updated
Oct 10, 2023

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.

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