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

Sponsor

Zhujiang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05291650

Collaborator

(none)

Enrollment

Location

Arms

7.2

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Drug: Glucocorticoids Drug: Saline Drug: Hyaluronic acid	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 25, 2022

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: glucocorticoid injection into infrapatellar fat pad	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. 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.
Placebo Comparator: placebo injection into infrapatellar fat pad	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. 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.

Arm

Intervention/Treatment

Active Comparator: glucocorticoid injection into infrapatellar fat pad

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.

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.

Placebo Comparator: placebo injection into infrapatellar fat pad

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.

Drug: Hyaluronic acid

Outcome Measures

Primary Outcome Measures

the knee pain change [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 [baseline and the 12th week]
the change of magnetic resonance imaging assessed effusion-synovitis volume

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.