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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Osteoarthritis of the Knee; Osteoarthritis of Knee; Osteoarthritis of the Knees; Osteoarthritis (OA) of the Knee; Osteoarthritis Knee; Osteoarthritis in the Knee; Osteoarthritis of Knee Joint
• Intervention / Treatment: Other: Sodium hyaluronate (hyaluronic acid); Drug: Methylprednisolone Acetate Injection

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bosnia and Herzegovina
  • Mostar, Bosnia and Herzegovina, 88000
    • Cantonal Hospital "dr.Safet Mujic"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyaluronic acid injection; This arm will receive a hyaluronic acid injection in the knee joint.	Other: Sodium hyaluronate (hyaluronic acid); The patient will receive one 3mL Sodium Hyaluronate injection containing 75 mg of active substance in one knee joint.
Active Comparator: Steroid injection; This arm will receive steroid injection in the knee joint.	Drug: Methylprednisolone Acetate Injection; The patient will receive 2mL of methylprednisolone acetate solution containing 80 mg of the medicine in other knee joint.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Edin Mešanović

Publications and helpful links

General Publications

• Ko NY, Chang CN, Cheng CH, Yu HK, Hu GC. Comparative Effectiveness of Focused Extracorporeal versus Radial Extracorporeal Shockwave Therapy for Knee Osteoarthritis-Randomized Controlled Study. Int J Environ Res Public Health. 2022 Jul 24;19(15):9001. doi: 10.3390/ijerph19159001.
• Mitra, S., Seenappa, H., & Madhavan, P. (2021). A clinical evaluation study of single spin vs double spin intra-articular prp injection in patients with bilateral early oa knee: a novel technique. International Journal of Orthopaedics Sciences, 7(3), 01-06. https://doi.org/10.22271/ortho.2021.v7.i3a.2718
• Rahman, S., Narhari, P., Sharifudin, M., & Aa, S. (2020). Western ontario and mcmaster universities (womac) osteoarthritis index as an assessment tool to indicate total knee arthroplasty in patients with primary knee osteoarthritis. Iium Medical Journal Malaysia, 19(3). https://doi.org/10.31436/imjm.v19i3.1664
• Wang SZ, Wu DY, Chang Q, Guo YD, Wang C, Fan WM. Intra-articular, single-shot co-injection of hyaluronic acid and corticosteroids in knee osteoarthritis: A randomized controlled trial. Exp Ther Med. 2018 Sep;16(3):1928-1934. doi: 10.3892/etm.2018.6371. Epub 2018 Jun 29.
• Metcalfe AJ, Andersson ML, Goodfellow R, Thorstensson CA. Is knee osteoarthritis a symmetrical disease? Analysis of a 12 year prospective cohort study. BMC Musculoskelet Disord. 2012 Aug 22;13:153. doi: 10.1186/1471-2474-13-153.
• Khalaj N, Abu Osman NA, Mokhtar AH, George J, Abas WA. Effect of intra-articular hyaluronic injection on postural stability and risk of fall in patients with bilateral knee osteoarthritis. ScientificWorldJournal. 2014;2014:815184. doi: 10.1155/2014/815184. Epub 2014 Jun 19.
• Cotofana S, Wirth W, Pena Rossi C, Eckstein F, Gunther OH. Contralateral knee effect on self-reported knee-specific function and global functional assessment: data from the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2015 Mar;67(3):374-81. doi: 10.1002/acr.22495.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: November 30, 2024
• First Submitted That Met QC Criteria: November 30, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: November 30, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: osteoarthritis; arthritis; hyaluronic acid; steroid injection; kellgren lawrence; oa
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protective Agents; Adjuvants, Immunologic; Neuroprotective Agents; Viscosupplements; Methylprednisolone Acetate; Prednisolone; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Hyaluronic Acid
• Other Study ID Numbers: 01-1-1-5469/23-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD, all IPD that underlie results in a publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No