Osteoarthritis, KneePhase 4NCT05291650
Ultrasound-guided Injection of Glucocorticoid Into Infrapatellar Fat Pad in Patients With Knee Osteoarthritis
A Phase 4 study testing Glucocorticoids, Saline and Hyaluronic acid in people with Osteoarthritis, Knee, run by Zhujiang Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Glucocorticoids, Saline and Hyaluronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2022to 26 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Injection of Glucocorticoid Into Infrapatellar Fat Pad Versus Placebo Injection in Knee Osteoarthritis: a 12-week Double-blinded Controlled Trial
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
- Being tested
- Glucocorticoids, Saline, Hyaluronic acid
- Keywords
- knee osteoarthritis, infrapatellar fat pad, inflammatory osteoarthritis, glucocorticoid
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucocorticoidsDrug
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.
SalineDrug
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 acidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| glucocorticoid injection into infrapatellar fat pad | Active comparator | Not described Receives: Drug: Glucocorticoids; Drug: Hyaluronic acid |
| placebo injection into infrapatellar fat pad | Placebo comparator | Not described Receives: Drug: Saline; Drug: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
the knee pain change
the knee pain change measured with visual analogue scale (VAS, 0-100), a higher VAS score means more severe pain
Measured: 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
Measured: over 12 weeks (assessed at baseline and the 12th week)
Secondary outcomes (6)
the change in WOMAC score
WOMAC is an abbreviation for Western Ontario and McMaster Universities Osteoarthritis Index. WOMAC evaluates patients' pain (five items), stiffness (two items), and functional dysfunction (17 items) over the last week, with each item measured on a 100-mm visual analog scale. The WOMAC score is calculated by summing the scores of each item, with a higher WOMAC score indicating more severe OA symptoms.
Measured: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)
the change in Hoffa-synovitis score
the Hoffa-synovitis score is assessed using the MRI Osteoarthritis Knee Score (MOAKS) method in MRI.
Measured: over 12 weeks (assessed at baseline and the 12th week)
the change in quality of life
quality of life is assessed using the four-dimensional Assessment of Quality of Life (AQoL-4D) questionnaire.
Measured: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)
the change in pain medication use
pain medication use is determined by the researchers from the records of medication use and categorized as commenced/increased, unchanged, or discontinued/decreased.
Measured: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)
the change in Infrapatellar fat pad volume
the infrapatellar fat pad volume is assessed using MRI.
Measured: over 12 weeks (assessed at baseline and the 12th week)
adverse reaction
adverse reactions are recorded at each follow-up, and the number of participants experiencing at least one adverse reaction is reported.
Measured: the 4th week, the 8th week, and the 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start25 Apr 2022
- Primary completion22 Sep 2023
- Study completion26 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291650
- Sponsor's protocol ID
- 2021-KY-183-02
- Status last verified
- Sep 2024
- First submitted
- 13 Mar 2022
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41481293Zhang 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.
PubMed 36597103
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Injection of Glucocorticoid Into Infrapatellar Fat Pad Versus Placebo Injection in Knee Osteoarthritis: a 12-week Double-blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT05291650
- Acronym / sponsor ID
- 2021-KY-183-02
- Conditions
- Osteoarthritis, Knee
- Keywords
- knee osteoarthritis, infrapatellar fat pad, inflammatory osteoarthritis, glucocorticoid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 26 Dec 2023 (actual)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucocorticoidsThe 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 | glucocorticoid injection into infrapatellar fat pad |
| SalineA 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 | placebo injection into infrapatellar fat pad |
| Hyaluronic acidAfter 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. | Drug | glucocorticoid injection into infrapatellar fat pad, placebo injection into infrapatellar fat pad |
Primary outcome
the knee pain change
Time frame: over 12 weeks (assessed at 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
Time frame: over 12 weeks (assessed at baseline and the 12th week)
the change of magnetic resonance imaging assessed effusion-synovitis volume
6 secondary outcomes
the change in WOMAC score
Time frame: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)
the change in Hoffa-synovitis score
Time frame: over 12 weeks (assessed at baseline and the 12th week)
the change in quality of life
Time frame: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)
the change in pain medication use
Time frame: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)
the change in Infrapatellar fat pad volume
Time frame: over 12 weeks (assessed at baseline and the 12th week)
adverse reaction
Time frame: the 4th week, the 8th week, and the 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 41481293Zhang 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.
- Derived from this study: PubMed 36597103Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucocorticoids, Saline and Hyaluronic acid in people with Osteoarthritis, Knee, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the knee pain change (time frame: over 12 weeks (assessed at baseline, the 4th week, the 8th week, and the 12th week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05291650, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.