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Completed

NCT Number: NCT06717529

Functional and Clinical Outcomes of Hyaluronic Acid and Steroid Injections in Bilateral Knee Osteoarthritis

The aim of this study is to compare functional and clinical outcomes of intraarticular injections of hyaluronic acid and steroids in patients with bilateral knee osteoarthritis. We will compare clinical and functional outcomes for each knee separately after week 6, month 3, month 6, and one year after the intervention.

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Key information

Conditions

Osteoarthritis (OA) of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis Knee Osteoarthritis in the Knee Osteoarthritis of Knee Osteoarthritis of Knee Joint Osteoarthritis of the Knee Osteoarthritis of the Knees Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cantonal Hospital "dr.Safet Mujic"

Mostar, 88000, Bosnia and Herzegovina

About this study

We will include patients with bilateral knee osteoarthritis (Kellgren Lawrence grades 2 and 3). On initial examination, we will measure active and passive range of flexion and extension, presence of swelling, joint effusion, VAS score for each knee separately, and WOMAC score for every knee separately. We will randomly apply hyaluronic acid injection in one knee and steroid injection in the other knee. We will repeat the same examination after week 6, month 3, month 6, and one year after the procedure. The main aim is to check whether there is a significant clinical or functional difference between two groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • bilateral knee pain
  • same grade of osteoarthritis in both knees
  • Kellgren-Lawrence grade 2 or 3 of knee osteoarthritis
  • fully completed all follow-up examinations

Exclusion criteria

  • unilateral knee osteoarthritis
  • different grade of osteoarthritis between knees based on Kellgren-Lawrence scale
  • positive history of previous knee interventions (injections, surgery)
  • positive history of additional knee injuries (meniscus, ligament...)

Treatment and study plan

Sodium hyaluronate (hyaluronic acid)

Other

The patient will receive one 3mL Sodium Hyaluronate injection containing 75 mg of active substance in one knee joint.

Methylprednisolone Acetate Injection

Drug

The patient will receive 2mL of methylprednisolone acetate solution containing 80 mg of the medicine in other knee joint.

Primary outcomes

  1. WOMAC score

    Time frame: One year after the intervention.

    Changes in WOMAC score one year after the intervention compared to the WOMAC score at the initial examination.

  2. VAS score

    Time frame: One year after the intervention.

    Changes in VAS score after one year.

  3. Range of active knee joint flexion

    Time frame: One year after the intervention.

    Changes in the range of active knee joint flexion

  4. Range of active knee joint extension

    Time frame: One year after the intervention.

    Changes in the range of active knee joint extension

  5. Knee swelling

    Time frame: One year after the intervention.

    Presence of knee joint swelling.

  6. Knee joint effusion

    Time frame: One year after the intervention.

    The presence of knee joint effusion.

Secondary outcomes

  1. WOMAC score after 6 weeks

    Time frame: 6 weeks after the intervention.

    Changes in WOMAC score compared to the initial examination.

  2. VAS score after 6 weeks

    Time frame: 6 weeks after the intervention.

    Changes in VAS score compared to the initial examination.

  3. Range of active knee joint flexion after 6 weeks

    Time frame: 6 weeks after the intervention.

    Changes in range of active knee joint flexion compared to the initial examination.

  4. Range of active knee joint extension after 6 weeks

    Time frame: 6 weeks after the intervention.

    Changes in the range of knee joint extension compared to the initial examination.

  5. Knee swelling after 6 weeks

    Time frame: 6 weeks after the intervention.

    Changes in the presence of knee swelling compared to the initial examination.

  6. Knee joint effusion after 6 weeks

    Time frame: 6 weeks after the intervention.

    Changes in the presence of knee joint effusion compared to the initial examination.

  7. WOMAC score after 3 months

    Time frame: 3 months after the intervention.

    Changes in WOMAC score compared to the initial examination.

  8. VAS score after 3 months

    Time frame: 3 months after the intervention.

    Changes in VAS score compared to the initial examination.

  9. Range of active knee joint flexion after 3 months

    Time frame: 3 months after the intervention.

    Changes in the range of knee joint flexion compared to the initial examination.

  10. Range of active knee joint extension after 3 months

    Time frame: 3 months after the intervention.

    Changes in the range of knee joint extension compared to the initial examination.

  11. Knee swelling after 3 months

    Time frame: 3 months after the intervention.

    Changes in the presence of knee swelling compared to the initial examination.

  12. Knee joint effusion after 3 months

    Time frame: 3 months after the intervention.

    Changes in the presence of knee joint effusion compared to the initial examination.

  13. WOMAC score after 6 months

    Time frame: 6 months after the intervention.

    Changes in WOMAC score compared to the initial examination.

  14. VAS score after 6 months

    Time frame: 6 months after the intervention.

    Changes in VAS score compared to the initial examination.

  15. Range of active knee joint flexion after 6 months

    Time frame: 6 months after the intervention.

    Changes in the range of knee joint flexion compared to the initial examination.

  16. Range of active knee joint extension after 6 months

    Time frame: 6 months after the intervention.

    Changes in the range of knee joint extension compared to the initial examination.

  17. Knee swelling after 6 months

    Time frame: 6 months after the intervention.

    Changes in the presence of knee swelling compared to the initial examination.

  18. Knee joint effusion after 6 months

    Time frame: 6 months after the intervention.

    Changes in the presence of knee effusion compared to the initial examination.

Sponsors and collaborators

Lead sponsor

Edin Mešanović

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

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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