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This aims of this study is to investigate the efficacy and safety of the glucocorticoid injection into the infrapatellar fat pad among knee osteoarthritis patients with an inflammatory phenotype.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| glucocorticoid injection into infrapatellar fat pad | Active Comparator |
| |
| placebo injection into infrapatellar fat pad | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucocorticoids | Drug | The product of the glucocorticoid is betamethasone injectable suspension and the dosage is 1 ml. To alleviate the discomfort on local tissues, the suspension injected into the infrapatellar fat pad will be pre-mixed with 0.5 ml saline and 0.5 ml lidocaine. That is, the total amount of the drug injected into the infrapatellar fat pad for the glucocorticoid group will be 2.0 ml. |
| Measure | Description | Time Frame |
|---|---|---|
| the knee pain change | the knee pain change measured with visual analogue scale (VAS, 0-100), a higher VAS score means more severe pain | over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week) |
| the change of effusion-synovitis volume | the change of magnetic resonance imaging assessed effusion-synovitis volume | over 12 weeks (assessed at baseline and the 12th week) |
| Measure | Description | Time Frame |
|---|---|---|
| the change in WOMAC score | WOMAC is an abbreviation for Western Ontario and McMaster Universities Osteoarthritis Index. WOMAC evaluates patients' pain (five items), stiffness (two items), and functional dysfunction (17 items) over the last week, with each item measured on a 100-mm visual analog scale. The WOMAC score is calculated by summing the scores of each item, with a higher WOMAC score indicating more severe OA symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital | Guangzhou | 510280 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41481293 | Derived | Zhang Y, Ruan G, Fan T, Zheng P, Zhu Z, He J, Wei X, Hu W, Huang S, Chang Q, Gao P, Chen H, Zhou X, Liu X, Tang S, Jiang L, Ding C. Infrapatellar Fat Pad Glucocorticoid Injection in Knee Osteoarthritis: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2549938. doi: 10.1001/jamanetworkopen.2025.49938. | |
| 36597103 | Derived |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D005938 | Glucocorticoids |
| D012965 | Sodium Chloride |
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
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|
| Saline | Drug | A total of 2.0 ml drug including 1.5 ml saline and 0.5 ml lidocaine will be injected into the infrapatellar fat pad for the placebo group. |
|
| Hyaluronic acid | Drug | After completing the process of infrapatellar fat pad injection, the participants in both groups will receive 2.5 ml hyaluronic acid suspension injection through the suprapatellar bursa into the intra-articular space. |
|
| over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week) |
| the change in Hoffa-synovitis score | the Hoffa-synovitis score is assessed using the MRI Osteoarthritis Knee Score (MOAKS) method in MRI. | over 12 weeks (assessed at baseline and the 12th week) |
| the change in quality of life | quality of life is assessed using the four-dimensional Assessment of Quality of Life (AQoL-4D) questionnaire. | over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week) |
| the change in pain medication use | pain medication use is determined by the researchers from the records of medication use and categorized as commenced/increased, unchanged, or discontinued/decreased. | over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week) |
| the change in Infrapatellar fat pad volume | the infrapatellar fat pad volume is assessed using MRI. | over 12 weeks (assessed at baseline and the 12th week) |
| adverse reaction | adverse reactions are recorded at each follow-up, and the number of participants experiencing at least one adverse reaction is reported. | the 4th week, the 8th week, and the 12th week |
| Zhang Y, Ruan G, Zheng P, Huang S, Zhou X, Liu X, Hu W, Feng H, Lin Y, He J, Wei Z, Zhang J, Chang Q, Wei X, Fan T, Jiang L, Ding C. Efficacy and safety of GLucocorticoid injections into InfrapaTellar faT pad in patients with knee ostEoarthRitiS: protocol for the GLITTERS randomized controlled trial. Trials. 2023 Jan 3;24(1):6. doi: 10.1186/s13063-022-06993-4. |
| D012216 |
| Rheumatic Diseases |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |