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Completed

NCT Number: NCT05291650

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

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhujiang Hospital

Guangzhou, 510280, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. the change in WOMAC score

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

    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.

  2. the change in Hoffa-synovitis score

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

    the Hoffa-synovitis score is assessed using the MRI Osteoarthritis Knee Score (MOAKS) method in MRI.

  3. the change in quality of life

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

    quality of life is assessed using the four-dimensional Assessment of Quality of Life (AQoL-4D) questionnaire.

  4. the change in pain medication use

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

    pain medication use is determined by the researchers from the records of medication use and categorized as commenced/increased, unchanged, or discontinued/decreased.

  5. the change in Infrapatellar fat pad volume

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

    the infrapatellar fat pad volume is assessed using MRI.

  6. adverse reaction

    Time frame: the 4th week, the 8th week, and the 12th week

    adverse reactions are recorded at each follow-up, and the number of participants experiencing at least one adverse reaction is reported.

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2022
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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