Ultrasound-guided Injection of Glucocorticoid Into Infrapatellar Fat Pad in Patients With Knee Osteoarthritis

Phase 4

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Saline; Drug: Glucocorticoids; Drug: Hyaluronic acid

• Registration Number: NCT05291650
• Lead Sponsor: Zhujiang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-13
• Study First Submitted QC: 2022-03-13
• Study First Posted: 2022-03-23
• Study Start: 2022-04-25
• Primary Completion: 2023-09-22
• Study Completion: 2023-12-26
• Status Verified: 2024-09
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo injection into infrapatellar fat pad	Saline	-
glucocorticoid injection into infrapatellar fat pad	Glucocorticoids	-
glucocorticoid injection into infrapatellar fat pad	Hyaluronic acid	-
placebo injection into infrapatellar fat pad	Hyaluronic acid	-

Primary Outcome Measures

Name	Time	Method
the knee pain change	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
the change of effusion-synovitis volume	over 12 weeks (assessed at baseline and the 12th week)	the change of magnetic resonance imaging assessed effusion-synovitis volume

Secondary Outcome Measures

Name	Time	Method
the change in WOMAC score	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.
the change in Hoffa-synovitis score	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.
the change in quality of life	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.
the change in pain medication use	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.
the change in Infrapatellar fat pad volume	over 12 weeks (assessed at baseline and the 12th week)	the infrapatellar fat pad volume is assessed using MRI.
adverse reaction	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.

Trial Locations

Locations (1)

Zhujiang Hospital; 🇨🇳 Guangzhou, China