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

Phase 4

Completed

• Conditions: Osteoarthritis (OA) of the Knee; Osteoarthritis; Osteoarthritis in the Knee; Osteoarthritis of Knee; Osteoarthritis of the Knees; Osteoarthritis of Knee Joint; Osteoarthritis Knee; Osteoarthritis of the Knee
• Interventions: Other: Sodium hyaluronate (hyaluronic acid); Drug: Methylprednisolone Acetate Injection

• Registration Number: NCT06717529
• Lead Sponsor: Edin Mešanović

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-11-15
• Study Completion: 2024-09-30
• Status Verified: 2024-11
• Study First Submitted: 2024-11-30
• Study First Submitted QC: 2024-11-30
• Last Update Submitted: 2024-11-30
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid injection	Sodium hyaluronate (hyaluronic acid)	This arm will receive a hyaluronic acid injection in the knee joint.
Steroid injection	Methylprednisolone Acetate Injection	This arm will receive steroid injection in the knee joint.

Primary Outcome Measures

Name	Time	Method
WOMAC score	One year after the intervention.	Changes in WOMAC score one year after the intervention compared to the WOMAC score at the initial examination.
VAS score	One year after the intervention.	Changes in VAS score after one year.
Range of active knee joint flexion	One year after the intervention.	Changes in the range of active knee joint flexion
Range of active knee joint extension	One year after the intervention.	Changes in the range of active knee joint extension
Knee swelling	One year after the intervention.	Presence of knee joint swelling.
Knee joint effusion	One year after the intervention.	The presence of knee joint effusion.

Secondary Outcome Measures

Name	Time	Method
WOMAC score after 6 weeks	6 weeks after the intervention.	Changes in WOMAC score compared to the initial examination.
VAS score after 6 weeks	6 weeks after the intervention.	Changes in VAS score compared to the initial examination.
Range of active knee joint flexion after 6 weeks	6 weeks after the intervention.	Changes in range of active knee joint flexion compared to the initial examination.
Range of active knee joint extension after 6 weeks	6 weeks after the intervention.	Changes in the range of knee joint extension compared to the initial examination.
Knee swelling after 6 weeks	6 weeks after the intervention.	Changes in the presence of knee swelling compared to the initial examination.
Knee joint effusion after 6 weeks	6 weeks after the intervention.	Changes in the presence of knee joint effusion compared to the initial examination.
WOMAC score after 3 months	3 months after the intervention.	Changes in WOMAC score compared to the initial examination.
VAS score after 3 months	3 months after the intervention.	Changes in VAS score compared to the initial examination.
Range of active knee joint flexion after 3 months	3 months after the intervention.	Changes in the range of knee joint flexion compared to the initial examination.
Range of active knee joint extension after 3 months	3 months after the intervention.	Changes in the range of knee joint extension compared to the initial examination.
Knee swelling after 3 months	3 months after the intervention.	Changes in the presence of knee swelling compared to the initial examination.
Knee joint effusion after 3 months	3 months after the intervention.	Changes in the presence of knee joint effusion compared to the initial examination.
WOMAC score after 6 months	6 months after the intervention.	Changes in WOMAC score compared to the initial examination.
VAS score after 6 months	6 months after the intervention.	Changes in VAS score compared to the initial examination.
Range of active knee joint flexion after 6 months	6 months after the intervention.	Changes in the range of knee joint flexion compared to the initial examination.
Range of active knee joint extension after 6 months	6 months after the intervention.	Changes in the range of knee joint extension compared to the initial examination.
Knee swelling after 6 months	6 months after the intervention.	Changes in the presence of knee swelling compared to the initial examination.
Knee joint effusion after 6 months	6 months after the intervention.	Changes in the presence of knee effusion compared to the initial examination.

Trial Locations

Locations (1)

Cantonal Hospital "dr.Safet Mujic"; 🇧🇦 Mostar, Bosnia and Herzegovina