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

Osteoarthritis, Knee Clinical Trial

Official title:

Ultrasound-guided Injection of Glucocorticoid Into Infrapatellar Fat Pad Versus Placebo Injection in Knee Osteoarthritis: a 12-week Double-blinded Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05291650
• Other study ID #: 2021-KY-183-02
• Status: Recruiting
• Phase: Phase 4
• Start date: April 25, 2022
• Est. completion date: December 2023

Study information

• Verified date: March 2022
• Source: Zhujiang Hospital
• Contact: Yan Zhang, PhD
• Phone: 13174122692
• Email: yan.zhang[@]utas.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Glucocorticoids
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.
• Saline
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
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.

Locations

Country	Name	City	State
China	Zhujiang Hospital	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the knee pain change	the knee pain change measured with visual analogue scale (VAS, 0-100), a higher VAS score means more severe pain	baseline, the 4th week, the 8th week, and the 12th week
Primary	the change of effusion-synovitis volume	the change of magnetic resonance imaging assessed effusion-synovitis volume	baseline and the 12th week