Clinical trial NCT06717529: Functional and Clinical Outcomes of Hyaluronic Acid and Steroid Injections in Bilateral Knee Osteoarthritis
Official title: Functional and Clinical Outcomes of Hyaluronic Acid and Steroid Injections in Bilateral Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Cantonal Hospital Dr. Safet Mujic Mostar
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with bilateral knee osteoarthritis will receive hyaluronic acid injection in one knee and steroid injection in the other knee.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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...)

Primary outcomes:
measure: WOMAC score
timeFrame: One year after the intervention.
measure: VAS score
timeFrame: One year after the intervention.
measure: Range of active knee joint flexion
timeFrame: One year after the intervention.
measure: Range of active knee joint extension
timeFrame: One year after the intervention.
measure: Knee swelling
timeFrame: One year after the intervention.
measure: Knee joint effusion
timeFrame: One year after the intervention.
Secondary outcomes:
measure: WOMAC score after 6 weeks
timeFrame: 6 weeks after the intervention.
measure: VAS score after 6 weeks
timeFrame: 6 weeks after the intervention.
measure: Range of active knee joint flexion after 6 weeks
timeFrame: 6 weeks after the intervention.
measure: Range of active knee joint extension after 6 weeks
timeFrame: 6 weeks after the intervention.
measure: Knee swelling after 6 weeks
timeFrame: 6 weeks after the intervention.
measure: Knee joint effusion after 6 weeks
timeFrame: 6 weeks after the intervention.
measure: WOMAC score after 3 months
timeFrame: 3 months after the intervention.
measure: VAS score after 3 months
timeFrame: 3 months after the intervention.
measure: Range of active knee joint flexion after 3 months
timeFrame: 3 months after the intervention.
measure: Range of active knee joint extension after 3 months
timeFrame: 3 months after the intervention.
measure: Knee swelling after 3 months
timeFrame: 3 months after the intervention.
measure: Knee joint effusion after 3 months
timeFrame: 3 months after the intervention.
measure: WOMAC score after 6 months
timeFrame: 6 months after the intervention.
measure: VAS score after 6 months
timeFrame: 6 months after the intervention.
measure: Range of active knee joint flexion after 6 months
timeFrame: 6 months after the intervention.
measure: Range of active knee joint extension after 6 months
timeFrame: 6 months after the intervention.
measure: Knee swelling after 6 months
timeFrame: 6 months after the intervention.
measure: Knee joint effusion after 6 months
timeFrame: 6 months after the intervention.
Other outcomes:
Locations:
city: Mostar
country: Bosnia and Herzegovina
facility: Cantonal Hospital "dr.Safet Mujic"
Study officials:
References:
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citation: 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
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.