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

NCT06717529 | Completed Phase 4

• 1 other identifier: 01-1-1-5469/23-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

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

Keywords

osteoarthritis; hyaluronic acid; steroid injection; kellgren lawrence; oa; arthritis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (18)

• WOMAC score after 6 weeks

  6 weeks after the intervention.

• VAS score after 6 weeks

  6 weeks after the intervention.

• Range of active knee joint flexion after 6 weeks

  6 weeks after the intervention.

• Range of active knee joint extension after 6 weeks

  6 weeks after the intervention.

• Knee swelling after 6 weeks

  6 weeks after the intervention.

Study Arms (2)

Hyaluronic acid injection

EXPERIMENTAL

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

Other: Sodium hyaluronate (hyaluronic acid)

Steroid injection

ACTIVE COMPARATOR

This arm will receive steroid injection in the knee joint.

Drug: Methylprednisolone Acetate Injection

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.

Hyaluronic acid injection

Methylprednisolone Acetate Injection DRUG

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

Steroid injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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...)

Sponsors & Collaborators

• Edin Mešanović: lead

Study Sites (1)

Cantonal Hospital "dr.Safet Mujic"

Mostar, 88000, Bosnia and Herzegovina

Location

Related Publications (7)

• 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.

  PMID: 35897371 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 30186420 BACKGROUND

• 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.

  PMID: 22917179 BACKGROUND

• 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.

  PMID: 25136689 BACKGROUND

• 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.

  PMID: 25302424 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Arthritis

Interventions

Hyaluronic Acid; Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopedic surgeon

Model Details: Patients with bilateral knee osteoarthritis will receive hyaluronic acid injection in one knee and steroid injection in the other knee.

Study Record Dates

• First Submitted: November 30, 2024
• First Posted: December 5, 2024
• Study Start: January 1, 2023
• Primary Completion: November 15, 2023
• Study Completion: September 30, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

BO (1)