Back to resultsUltrasound-guided Injection of Glucocorticoid Into Infrapatellar Fat Pad in Patients With Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Glucocorticoids
Saline
Hyaluronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring knee osteoarthritis, infrapatellar fat pad, inflammatory osteoarthritis, glucocorticoid
Eligibility Criteria
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.
Sites / Locations
- Zhujiang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
glucocorticoid injection into infrapatellar fat pad
placebo injection into infrapatellar fat pad
Arm Description
Outcomes
Primary Outcome Measures
the knee pain change
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
the change of magnetic resonance imaging assessed effusion-synovitis volume
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05291650
Brief Title
Ultrasound-guided Injection of Glucocorticoid Into Infrapatellar Fat Pad in Patients With Knee Osteoarthritis
Official Title
Ultrasound-guided Injection of Glucocorticoid Into Infrapatellar Fat Pad Versus Placebo Injection in Knee Osteoarthritis: a 12-week Double-blinded Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
knee osteoarthritis, infrapatellar fat pad, inflammatory osteoarthritis, glucocorticoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
glucocorticoid injection into infrapatellar fat pad
Arm Type
Active Comparator
Arm Title
placebo injection into infrapatellar fat pad
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Glucocorticoids
Intervention Description
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
Intervention Name(s)
Saline
Intervention Description
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
Intervention Name(s)
Hyaluronic acid
Intervention Description
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.
Primary Outcome Measure Information:
Title
the knee pain change
Description
the knee pain change measured with visual analogue scale (VAS, 0-100), a higher VAS score means more severe pain
Time Frame
baseline, the 4th week, the 8th week, and the 12th week
Title
the change of effusion-synovitis volume
Description
the change of magnetic resonance imaging assessed effusion-synovitis volume
Time Frame
baseline and the 12th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhang, PhD
Phone
13174122692
Ext
+86
Email
yan.zhang@utas.edu.au
Facility Information:
Facility Name
Zhujiang Hospital
City
Guangzhou
ZIP/Postal Code
510280
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhang, PhD
Phone
+8613174122692
Email
yan.zhang@utas.edu.au
12. IPD Sharing Statement
Learn more about this trial
Ultrasound-guided Injection of Glucocorticoid Into Infrapatellar Fat Pad in Patients With Knee Osteoarthritis
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