UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040982 |
|---|---|
| Receipt number | R000046795 |
| Scientific Title | The effect of infrapatellar fat pad on anterior knee pain in patients with knee osteoarthritis |
| Date of disclosure of the study information | 2020/07/02 |
| Last modified on | 2024/01/04 14:05:57 |
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Basic information
Public title
The effect of infrapatellar fat pad on anterior knee pain in patients with knee osteoarthritis
Acronym
The effect of infrapatellar fat pad on anterior knee pain in patients with knee osteoarthritis
Scientific Title
The effect of infrapatellar fat pad on anterior knee pain in patients with knee osteoarthritis
Scientific Title:Acronym
The effect of infrapatellar fat pad on anterior knee pain in patients with knee osteoarthritis
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the infrapatellar fat pad in patients with knee osteoarthritis with anterior knee pain
Basic objectives2
Others
Basic objectives -Others
To clarify the factors that affect anterior knee pain
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between anterior knee pain and image of infrapatellar fat pad
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Knee Osteoarthritis (Kellgren Lawrence grade >=2)
Key exclusion criteria
1)History of surgery on ipsilateral knee
2)Systemic inflammatory arthritis (RA etc.)
3)Cognitive decline due to psychiatric disorders
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Satake |
Organization
Kochi Medical School, Kochi University
Division name
Department of Orthopaedic Surgery
Zip code
783-8505
Address
Kohasu, Okoh-cho, Nankoku-City, Kochi, JAPAN
TEL
088-880-2387
im35@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Taniuchi |
| Middle name | |
| Last name | Miho |
Organization
Kochi Medical School, Kochi University
Division name
Department of Orthopaedic Surgery
Zip code
783-8505
Address
Kohasu, Okoh-cho, Nankoku-City, Kochi, JAPAN
TEL
088-880-2387
Homepage URL
im35@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Kochi Medical School
Address
Kohasu, Okoh-cho, Nankoku-City, Kochi, JAPAN
Tel
088-880-2180
is21@kochi-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 02 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-023-47459-0
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-023-47459-0
Number of participants that the trial has enrolled
120
Results
The IPFP was significantly smaller as the KL grade severity of the FT joint increased. The shear wave speed was significantly associated with anterior knee pain in the univariate analyses. Logistic regression analyses indicated that shear wave speed was the only significant explanatory variable of anterior knee pain.
Results date posted
| 2024 | Year | 01 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients diagnosed with KOA (Kellgren and Lawrence grade over 2)
Participant flow
On the first visit, the demographic data of the patients were assessed and knee radiography and pressure pain threshold (PPT) measurements of the IPFP were performed. Knee MRI and ultrasound elastography of the IPFP were conducted on a different day. Partial excision biopsies of the IPFP were performed in patients who subsequently underwent knee surgery.
Adverse events
N/A
Outcome measures
The relationship between the IPFP characteristics (size and elasticity) and the KL grade of the FT joint.
Predisposing factors associated with anterior knee pain.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Image evaluation such as X-ray and MRI, and pain scoring are performed in patients with knee osteoarthritis. We statistically analyze the factors related to anterior knee pain from them.
Management information
Registered date
| 2020 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046795
