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

Edin Mešanović

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis in the Knee; Osteoarthritis; Osteoarthritis of the Knee; Osteoarthritis Knee; Osteoarthritis of Knee; Osteoarthritis (OA) of the Knee; Osteoarthritis of Knee Joint; Osteoarthritis of the Knees

Treatments: Drug: Methylprednisolone Acetate Injection; Other: Sodium hyaluronate (hyaluronic acid)

Study type: Interventional

Funder types: Other

Identifiers

NCT06717529

01-1-1-5469/23-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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...)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 2 patient groups

Hyaluronic acid injection

Experimental group

Description:

This arm will receive a hyaluronic acid injection in the knee joint.

Treatment:

Other: Sodium hyaluronate (hyaluronic acid)

Steroid injection

Active Comparator group

Description:

This arm will receive steroid injection in the knee joint.

Treatment:

Drug: Methylprednisolone Acetate Injection