Clinical trial NCT05291650: Ultrasound-guided Injection of Glucocorticoid Into Infrapatellar Fat Pad in Patients With Knee Osteoarthritis
Official title: Ultrasound-guided Injection of Glucocorticoid Into Infrapatellar Fat Pad Versus Placebo Injection in Knee Osteoarthritis: a 12-week Double-blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: knee osteoarthritis
infrapatellar fat pad
inflammatory osteoarthritis
glucocorticoid
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with symptomatic knee osteoarthritis (OA) according to American College of Rheumatology criteria;
2. Age \> 45 years;
3. Have knee pain for more than six months and the knee pain over the past week assessed by VAS (100 mm) ≥ 40 mm;
4. Ultrasonography showed obvious synovitis with effusion in the knee joint;
5. Both MRI-assessed Hoffa-synovitis score (MOAKS method) and effusion-synovitis score (modified WORMS method) ≥ 1, and their total score ≥ 3;
6. Being able to listen, speak, read and understand Chinese, capable of understanding the study requirements and cooperating with the researchers during the study, and providing written informed consent.

Exclusion Criteria:

1. Allergy to glucocorticoids;
2. Knee injection of glucocorticoid or hyaluronic acid within the past six months;
3. Severe trauma or arthroscopy in the knee within the past six months;
4. Planned hip or knee surgery (including arthroscopy, arthroplasty, and other open joint surgeries) in the next six months;
5. Contraindication to having magnetic resonance imaging (MRI) (e.g., implanted pacemaker, artificial metal valve or cornea, aneurysm clipping surgery, arterial dissection, metal foreign bodies in the eyeball, claustrophobia);
6. Presence of other arthritis, such as rheumatoid arthritis and psoriatic arthritis;
7. Other physical condition that is more painful than their knee OA;
8. Malignant tumors or other life-threatening diseases;
9. Infection, diabetes, coagulopathy, osteonecrosis, or gastric/duodenal ulcer within the past 12 months;
10. Current use of oral corticosteroids, nonsteroidal anti-inflammatory drugs, or immunosuppressive medication;
11. Pregnancy or lactating female;
12. Use any investigational drugs or devices in the recent 30 days.

Primary outcomes:
measure: the knee pain change
timeFrame: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)
measure: the change of effusion-synovitis volume
timeFrame: over 12 weeks (assessed at baseline and the 12th week)
Secondary outcomes:
measure: the change in WOMAC score
timeFrame: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)
measure: the change in Hoffa-synovitis score
timeFrame: over 12 weeks (assessed at baseline and the 12th week)
measure: the change in quality of life
timeFrame: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)
measure: the change in pain medication use
timeFrame: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)
measure: the change in Infrapatellar fat pad volume
timeFrame: over 12 weeks (assessed at baseline and the 12th week)
measure: adverse reaction
timeFrame: the 4th week, the 8th week, and the 12th week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital
Study officials:
References: