UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042285
Receipt number R000048271
Scientific Title Three-dimensional volume and shape of the infrapatellar fat pad during quasi-static knee extension between before and after arthroscopic surgery: prospective cohort study
Date of disclosure of the study information 2020/11/01
Last modified on 2022/10/31 12:30:54

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Basic information

Public title

Dynamics of infrapatellar fat pad between before and after arthroscopic surgery: prospective cohort study

Acronym

Dynamics of infrapatellar fat pad between before and after arthroscopic surgery: prospective cohort study

Scientific Title

Three-dimensional volume and shape of the infrapatellar fat pad during quasi-static knee extension between before and after arthroscopic surgery: prospective cohort study

Scientific Title:Acronym

Three-dimensional volume and shape of the infrapatellar fat pad during quasi-static knee extension between before and after arthroscopic surgery: prospective cohort study

Region

Japan


Condition

Condition

Undergoing arthroscopic surgery

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate changes in the dynamic shape of the infrapatellar fat pad between before and after arthroscopy using a three-dimensional model of the infrapatellar fat pad.

Basic objectives2

Others

Basic objectives -Others

To investigate association the dynamic shape of the infrapatellar fat pad and angle and length of the patellar tendon between before and after arthroscopy using a three-dimensional model of the infrapatellar fat pad.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

MRI before and after arthroscopic surgery

Key secondary outcomes

Range of motion of the knee joint
Performance test(Weight bearing index, Single Leg Hop test)
At possible to return to sports without restrictions


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

10 years-old <=

Age-upper limit

40 years-old >=

Gender

Male and Female

Key inclusion criteria

Those who can follow up until complete return to sports or the end of Orthopedic examination at our hospital

Key exclusion criteria

Those who can not follow up until complete return to sports or the end of Orthopedic examinationat our hospital
Those who has pain not related arthoroscopy
Those who are with a history of surgery on the lower limbs

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yuriko
Middle name
Last name Okita

Organization

Sadamatsu Hospital

Division name

Department of Rehabilitation

Zip code

856-0831

Address

Higashihonmachi537, Omura, Nagasaki, Japan

TEL

0957-54-1161

Email

yuriko.okita.517@gmail.com


Public contact

Name of contact person

1st name Yuriko
Middle name
Last name Okita

Organization

Sadamatsu Hospital

Division name

Department of Rehabilitation

Zip code

856-0831

Address

Higashihonmachi537, Omura, Nagasaki, Japan

TEL

0957-54-1161

Homepage URL

https://sadamatsu-hp.wixsite.com/home

Email

yuriko.okita.517@gmail.com


Sponsor or person

Institute

Department of Rehabilitation, Sadamatsu Hospital

Institute

Department

Personal name



Funding Source

Organization

No funding

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Sadamatsu Hospital

Address

Higashihonmachi537, Omura, Nagasaki, Japan

Tel

0957-54-1161

Email

yuriko.okita.517@gmail.com


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 11 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

16

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

the patients who got an arthroscopy surgery in our hospital with agree for participation

Participant flow

the patients take a MRI before surgery.
And after they return to sports, they take it again.

Adverse events

nothing

Outcome measures

MRI
Weight, Height, age

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2019 Year 01 Month 30 Day

Date of IRB

2019 Year 02 Month 09 Day

Anticipated trial start date

2019 Year 05 Month 01 Day

Last follow-up date

2024 Year 02 Month 10 Day

Date of closure to data entry

2024 Year 08 Month 31 Day

Date trial data considered complete

2024 Year 12 Month 31 Day

Date analysis concluded

2025 Year 03 Month 31 Day


Other

Other related information

Subjects were taken MRI before arthroscopic surgery. After arthroscopic surgery, they received normal rehabilitation according to rehabilitation protocol. After that, they were taken MRI as follow-up for those who meet the criteria. And we analyzed using that data.


Management information

Registered date

2020 Year 10 Month 29 Day

Last modified on

2022 Year 10 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048271


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name