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

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Completed
CT.gov ID
NCT05439317
Collaborator
(none)
33
Enrollment
1
Location
4.2
Actual Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    33 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Elasticity of the Hoffa's Fat Pad in Patients With Knee Osteoarthritis
    Actual Study Start Date :
    Dec 3, 2021
    Actual Primary Completion Date :
    Apr 11, 2022
    Actual Study Completion Date :
    Apr 11, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    knee osteoarthritis group

    individuals being diagnosed with osteoarthritis and classified by K-L grading
    healthy group

    individuals without knee pain or diagnosis of knee osteoarthritis

    Outcome Measures

    Primary Outcome Measures

    1. shear modulus [before and 1-3 months after hyaluronic acid injection]

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

    2. strain ratio [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 [before and 1-3 months after hyaluronic acid injection]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 86 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taipei Veterans General Hospital Taipei Taiwan

    Sponsors and Collaborators

    • Taipei Veterans General Hospital, Taiwan

    Investigators

    • Study Chair: Ding-Hao Liu, Physical and Rehabilitation Medicine, Veterans General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taipei Veterans General Hospital, Taiwan
    ClinicalTrials.gov Identifier:
    NCT05439317
    Other Study ID Numbers:
    • 2021-09-013AC
    First Posted:
    Jun 30, 2022
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee

    Study Results

    No Results Posted as of Jun 30, 2022