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

NCT ID: NCT05291650

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-25
• Study Completion Date: 2023-12-26

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.

Conditions

Osteoarthritis, Knee

Keywords

knee osteoarthritis; infrapatellar fat pad; inflammatory osteoarthritis; glucocorticoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

glucocorticoid injection into infrapatellar fat pad

Group Type: ACTIVE_COMPARATOR

Glucocorticoids

Intervention Type: 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.

Hyaluronic acid

Intervention Type: 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.

placebo injection into infrapatellar fat pad

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhujiang Hospital

Guangzhou, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 36597103 (View on PubMed)

Other Identifiers

2021-KY-183-02

Identifier Type: -

Identifier Source: org_study_id