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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic acid injection | Experimental | This arm will receive a hyaluronic acid injection in the knee joint. |
|
| Steroid injection | Active Comparator | This arm will receive steroid injection in the knee joint. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium hyaluronate (hyaluronic acid) | Other | The patient will receive one 3mL Sodium Hyaluronate injection containing 75 mg of active substance in one knee joint. |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cantonal Hospital "dr.Safet Mujic" | Mostar | 88000 | Bosnia and Herzegovina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35897371 | Background | 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. | |
| 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 | ||
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All collected IPD, all IPD that underlie results in a publication.
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Patients with bilateral knee osteoarthritis will receive hyaluronic acid injection in one knee and steroid injection in the other knee.
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| Methylprednisolone Acetate Injection | Drug | The patient will receive 2mL of methylprednisolone acetate solution containing 80 mg of the medicine in other knee joint. |
|
| 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. |
| 30186420 |
| 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. |
| 22917179 | 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. |
| 25136689 | 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. |
| 25302424 | 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. |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D000077555 | Methylprednisolone Acetate |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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