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NCT Number: NCT03761472

Comparison of Hyaluronic Acid and Platelet-rich Plasma Injections

This study aims to compare the effects of hyaluronic acid injection and platelet rich plasma injection in terms of pain, physical function and femoral cartilage thickness in short term treatment in patients with knee osteoarthritis.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

Platelet-rich plasma and hyaluronic acid injections are both popular treatments and commonly used for treatment of knee osteoarthritis. Even though there are many studies investigating the effectiveness of these treatments, the results are mostly qualitative. Also there are a few studies comparing these two treatment modalities. In this study the investigators aim to compare these modalities both for self-reported data (pain, physical function) and objective measurement data (femoral cartilage thickness via ultrasonography). Patients with unilateral osteoarthritis/unilateral complaint will be included in the study. Unaffected side will be controls for each group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is able to consent
  • Subject meets Osteoarthritis Research Society International (OARSI) criteria for knee osteoarthritis
  • Subject has radiographic Kellgren-Lawrence grade 2-3 osteoarthritis
  • Unilateral osteoarthritis/complaint

Exclusion criteria

  • Past or actual knee infection
  • History of surgery, fracture on knee
  • Collagen tissue disease
  • Systemic inflammatory disease (rheumatoid arthritis, spondyloarthritis etc.)
  • Systemic diseases (diabetes, hematologic diseases, endocrinopathies, renal failure, liver failure)
  • Knee injection in past 6 months
  • Immunodeficiency
  • Pregnant/breastfeeding
  • Malignancy

Treatment and study plan

Hyaluronic acid injection

Biological

Hyaluronic acid 48 mg 2.0% in 2.4 ml solution

Other names: Reviscon Mono

Platelet-rich plasma injection

Biological

Platelet-rich plasma injection 5ml

Primary outcomes

  1. Change of numeric rating scale (rest, movement)

    Time frame: 0, 1st, 6th, months

    Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.

  2. Change of Western Ontario and McMaster Universities Osteoarthritis Index score(WOMAC)

    Time frame: 0, 1st, 6th months

    Self reported questionnaire investigating 24 daily living activities. Each item is scored 0-5 (0:none 5:worst). Yielding a total between 0-100. Higher scores represent a worse outcome.

  3. Change of femoral cartilage thickness via ultrasonography.

    Time frame: 0, 1st, 6th months

    Transverse plane femoral cartilage thickness from three landmarks (from articular cartilage pothole,from midpoint of medial border and pothole of cartilage, from midpoint of lateral border and pothole of cartilage). Measured in millimeters. The sum of three points indicate a total thickness. A higher measurement indicates a thicker cartilage representing a better outcome.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Comparison of Hyaluronic Acid and Platelet-rich Plasma Injection on Pain, Physical Function and Femoral Cartilage Thickness in Patients With Osteoarthritis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 3, 2018
Registry last updated
Jan 18, 2020

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.

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