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

NCT ID: NCT06717529

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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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

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osteoarthritis hyaluronic acid steroid injection kellgren lawrence oa arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with bilateral knee osteoarthritis will receive hyaluronic acid injection in one knee and steroid injection in the other knee.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hyaluronic acid injection

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

Group Type EXPERIMENTAL

Sodium hyaluronate (hyaluronic acid)

Intervention Type OTHER

The patient will receive one 3mL Sodium Hyaluronate injection containing 75 mg of active substance in one knee joint.

Steroid injection

This arm will receive steroid injection in the knee joint.

Group Type ACTIVE_COMPARATOR

Methylprednisolone Acetate Injection

Intervention Type DRUG

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

Interventions

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Sodium hyaluronate (hyaluronic acid)

The patient will receive one 3mL Sodium Hyaluronate injection containing 75 mg of active substance in one knee joint.

Intervention Type OTHER

Methylprednisolone Acetate Injection

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

Intervention Type DRUG

Eligibility Criteria

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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...)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edin Mešanović

OTHER

Sponsor Role lead

Responsible Party

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Edin Mešanović

Orthopedic surgeon

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Cantonal Hospital "dr.Safet Mujic"

Mostar, , Bosnia and Herzegovina

Site Status

Countries

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Bosnia and Herzegovina

References

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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.

Reference Type BACKGROUND
PMID: 35897371 (View on PubMed)

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

Reference Type 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

Reference Type 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.

Reference Type BACKGROUND
PMID: 30186420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22917179 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25136689 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25302424 (View on PubMed)

Other Identifiers

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01-1-1-5469/23-01

Identifier Type: -

Identifier Source: org_study_id