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

Edin Mešanović65 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis (OA) of the Knee Osteoarthritis Osteoarthritis in the Knee

Interventions

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 InjectionDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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...)

Outcomes

Primary Outcomes

WOMAC score

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

Time frame: One year after the intervention.

VAS score

Changes in VAS score after one year.

Time frame: One year after the intervention.

Range of active knee joint flexion

Changes in the range of active knee joint flexion

Time frame: One year after the intervention.

Range of active knee joint extension

Changes in the range of active knee joint extension

Time frame: One year after the intervention.

Knee swelling

Presence of knee joint swelling.

Time frame: One year after the intervention.

Knee joint effusion

The presence of knee joint effusion.

Time frame: One year after the intervention.

Secondary Outcomes

WOMAC score after 6 weeks

Changes in WOMAC score compared to the initial examination.

Time frame: 6 weeks after the intervention.

VAS score after 6 weeks

Changes in VAS score compared to the initial examination.

Time frame: 6 weeks after the intervention.

Range of active knee joint flexion after 6 weeks

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

Time frame: 6 weeks after the intervention.

Range of active knee joint extension after 6 weeks

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

Time frame: 6 weeks after the intervention.

Knee swelling after 6 weeks

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

Time frame: 6 weeks after the intervention.

Knee joint effusion after 6 weeks

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

Time frame: 6 weeks after the intervention.

WOMAC score after 3 months

Changes in WOMAC score compared to the initial examination.

Time frame: 3 months after the intervention.

VAS score after 3 months

Changes in VAS score compared to the initial examination.

Time frame: 3 months after the intervention.

Range of active knee joint flexion after 3 months

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

Time frame: 3 months after the intervention.

Range of active knee joint extension after 3 months

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

Time frame: 3 months after the intervention.

Knee swelling after 3 months

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

Time frame: 3 months after the intervention.

Knee joint effusion after 3 months

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

Time frame: 3 months after the intervention.

WOMAC score after 6 months

Changes in WOMAC score compared to the initial examination.