NCT05439317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 19, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

May 19, 2022

Last Update Submit

February 20, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • shear modulus

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

    before and 1-3 months after hyaluronic acid injection

  • strain ratio

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

    before and 1-3 months after hyaluronic acid injection

  • thickness of Hoffa's fat pad

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

    before and 1-3 months after hyaluronic acid injection

Study Arms (2)

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

Eligibility Criteria

Age20 Years - 86 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

individuals with knee osteoarthritis diagnosis is classified as K-L grading I - IV individuals in control group has no knee pain or osteoarthritis history

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ding-Hao Liu

    Physical and Rehabilitation Medicine, Veterans General Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2022

First Posted

June 30, 2022

Study Start

December 3, 2021

Primary Completion

April 11, 2022

Study Completion

August 5, 2022

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations