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Completed

NCT Number: NCT05439317

Elasticity of the Hoffa's Fat Pad in Patients With Knee Osteoarthritis

Knee osteoarthritis (OA) is a common problem in clinical settings. Knee OA is well known for its association with the wear and tear of the cartilage and osteophyte formation. Evidence has suggested the importance of the infrapatellar fat pad, known as Hoffa's fat pad, during the development of knee OA. Some studies have demonstrated the protective role of the infrapatellar fat pad, whereas others have suggested an inflammatory role such as increased fibrosis and proinflammatory cytokine levels. Ultrasound is exceptionally convenient in the assessment of the musculoskeletal system, and elastography is a tool to evaluate tissue texture. Therefore, in this study, we investigated the Hoffa's fat pad in knee OA patients by using elastography.

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Key information

Age range

20 year–86 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Veterans General Hospital

Taipei, Taiwan

About this study

This was an observation study that included a control group. We enrolled 20 patients with knee OA, as well as 10 healthy individuals. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Kellgren-Lawrence X-ray grading were employed to determine disease severity. All the study participants received elastography assessment, including strain and shear wave elastography in the knee extension and flexion position. The strain elastography contained color mapping that enabled the calculation of the relative texture and strain ratio. The shear wave elastography revealed the qualitative velocity, which was measured 3 times. Each patients with knee OA received elastography examination twice: once before hyaluronic acid injection and once 1 month after the injection.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

OA group

  • Kellgren-Lawrence grading I-IV proved by knee X-ray Healthy group
  • No knee pain or received injection during the past 1 year
  • No history of knee OA

Exclusion criteria

  • History of knee surgery, trauma or malignancy
  • History of patellar tendinopathy or patellofemoral pain syndrome
  • Refused informed consent

Treatment and study plan

Primary outcomes

  1. shear modulus

    Time frame: before and 1-3 months after hyaluronic acid injection

    the absolute quantitative measurement of elasticity (kPa) of Hoffa's fat pad

  2. strain ratio

    Time frame: before and 1-3 months after hyaluronic acid injection

    the semiquantitative measurement of elasticity of Hoffa's fat pad, a ratio with patellar tendon as reference

  3. thickness of Hoffa's fat pad

    Time frame: before and 1-3 months after hyaluronic acid injection

    the thickness of Hoffa's fat pad from mid patellar tendon to femur cartilage

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 30, 2022
Registry last updated
Feb 22, 2023

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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