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

NCT05291650 | Completed Phase 4

• 1 other identifier: 2021-KY-183-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• the knee pain change

  the knee pain change measured with visual analogue scale (VAS, 0-100), a higher VAS score means more severe pain

  over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)

• the change of effusion-synovitis volume

  the change of magnetic resonance imaging assessed effusion-synovitis volume

  over 12 weeks (assessed at baseline and the 12th week)

Secondary Outcomes (6)

• the change in WOMAC score

  over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)

• the change in Hoffa-synovitis score

  over 12 weeks (assessed at baseline and the 12th week)

• the change in quality of life

  over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)

• the change in pain medication use

  over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)

• the change in Infrapatellar fat pad volume

  over 12 weeks (assessed at baseline and the 12th week)

Study Arms (2)

glucocorticoid injection into infrapatellar fat pad

ACTIVE COMPARATOR

Drug: Glucocorticoids; Drug: Hyaluronic acid

placebo injection into infrapatellar fat pad

PLACEBO COMPARATOR

Drug: Saline; Drug: Hyaluronic acid

Interventions

Glucocorticoids 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.

glucocorticoid injection into infrapatellar fat pad

Saline 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.

placebo injection into infrapatellar fat pad

Hyaluronic acid 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.

glucocorticoid injection into infrapatellar fat pad; placebo injection into infrapatellar fat pad

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with symptomatic knee osteoarthritis (OA) according to American College of Rheumatology criteria;
• Age \> 45 years;
• Have knee pain for more than six months and the knee pain over the past week assessed by VAS (100 mm) ≥ 40 mm;
• Ultrasonography showed obvious synovitis with effusion in the knee joint;
• Both MRI-assessed Hoffa-synovitis score (MOAKS method) and effusion-synovitis score (modified WORMS method) ≥ 1, and their total score ≥ 3;
• 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.

You may not qualify if:

• Allergy to glucocorticoids;
• Knee injection of glucocorticoid or hyaluronic acid within the past six months;
• Severe trauma or arthroscopy in the knee within the past six months;
• Planned hip or knee surgery (including arthroscopy, arthroplasty, and other open joint surgeries) in the next six months;
• 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);
• Presence of other arthritis, such as rheumatoid arthritis and psoriatic arthritis;
• Other physical condition that is more painful than their knee OA;
• Malignant tumors or other life-threatening diseases;
• Infection, diabetes, coagulopathy, osteonecrosis, or gastric/duodenal ulcer within the past 12 months;
• Current use of oral corticosteroids, nonsteroidal anti-inflammatory drugs, or immunosuppressive medication;
• Pregnancy or lactating female;
• Use any investigational drugs or devices in the recent 30 days.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital

Guangzhou, 510280, China

Location

Related Publications (2)

• Zhang Y, Ruan G, Fan T, Zheng P, Zhu Z, He J, Wei X, Hu W, Huang S, Chang Q, Gao P, Chen H, Zhou X, Liu X, Tang S, Jiang L, Ding C. Infrapatellar Fat Pad Glucocorticoid Injection in Knee Osteoarthritis: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2549938. doi: 10.1001/jamanetworkopen.2025.49938.

  PMID: 41481293 DERIVED

• 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.

  PMID: 36597103 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Glucocorticoids; Sodium Chloride; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2022
• First Posted: March 23, 2022
• Study Start: April 25, 2022
• Primary Completion: September 22, 2023
• Study Completion: December 26, 2023
• Last Updated: December 5, 2024

Record last verified: 2024-09

Locations

CN (1)