Zhujiang Hospital
Guangzhou, 510280, China
NCT Number: NCT05291650
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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Notify Me45 year and older
All sexes
Interventional
Phase 4
Guangzhou, 510280, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)
the knee pain change measured with visual analogue scale (VAS, 0-100), a higher VAS score means more severe pain
Time frame: over 12 weeks (assessed at baseline and the 12th week)
the change of magnetic resonance imaging assessed effusion-synovitis volume
Time frame: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)
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.
Time frame: over 12 weeks (assessed at baseline and the 12th week)
the Hoffa-synovitis score is assessed using the MRI Osteoarthritis Knee Score (MOAKS) method in MRI.
Time frame: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)
quality of life is assessed using the four-dimensional Assessment of Quality of Life (AQoL-4D) questionnaire.
Time frame: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)
pain medication use is determined by the researchers from the records of medication use and categorized as commenced/increased, unchanged, or discontinued/decreased.
Time frame: over 12 weeks (assessed at baseline and the 12th week)
the infrapatellar fat pad volume is assessed using MRI.
Time frame: the 4th week, the 8th week, and the 12th week
adverse reactions are recorded at each follow-up, and the number of participants experiencing at least one adverse reaction is reported.
Zhujiang Hospital
Other
Ultrasound-guided Injection of Glucocorticoid Into Infrapatellar Fat Pad Versus Placebo Injection in Knee Osteoarthritis: a 12-week Double-blinded Controlled Trial
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