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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020540
Receipt No. R000023648
Scientific Title Randomized controlled trial about the lymph drainage intervention in the physiotherapy after the total knee arthroplasty
Date of disclosure of the study information 2016/01/13
Last modified on 2019/01/14

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Basic information
Public title Randomized controlled trial about the lymph drainage intervention in the physiotherapy after the total knee arthroplasty
Acronym RCT examination about the lymph drainage intervention after the total knee replacement
Scientific Title Randomized controlled trial about the lymph drainage intervention in the physiotherapy after the total knee arthroplasty
Scientific Title:Acronym RCT examination about the lymph drainage intervention after the total knee replacement
Region
Japan

Condition
Condition knee osteoarthritis
Classification by specialty
Surgery in general Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For a patient of acute phase after the total knee arthroplasty, I inspect the effectiveness of the inflammatory symptom (a feeling of sharp pain, swelling, heat, functional disorder) reduction by the lymph drainage intervention.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes pain of about the tenth day after surgery
Key secondary outcomes circumference,muscle strength,maximum gait velocity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The intervention group does it in addition to the normal physiotherapy of approximately 40 minutes with a group giving the lymph drainage of 20 minutes. I do it after an operation after an operation until the tenth day from the third day during the period and carry out the frequency five times once a day within a period.
Interventions/Control_2 The control group assumes it a group giving only the normal physiotherapy of approximately 40 minutes.
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
45 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria (1)The age at registration is a patient younger than 85 years 45 years old or older
(2)The patient who agreed to osteoarthrosis being diagnosed, and doing total knee arthroplasty
(3)The patient who has not been for the joint by total knee arthroplasty so far.
(4)The patient who plans unilateral total knee arthroplasty.
(5)The patient who was able to perform intervention of the physical therapy before operation.
(6)The patient that an answer to questionary survey is possible.
(7)The patient that an agreement is provided in a document about the participation of this study.
Key exclusion criteria (1)It is a patient with the past with deep vein thrombosis or heart failure.
(2)Under 45 years old, patient 85 years or older
(3)The patient who receives total knee arthroplasty at the both sides same time.
(4)Severe cognitive functional decline and patient with a mental disorder.
(5)In addition, the patient whom it was judged the judgment of the doctor to be inappropriate as an object.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsu Fujiura
Organization yokohama city university medical center
Division name rehabilitation division
Zip code
Address 4-57, Urafunecho, Minami-ku, Yokohama-shi, Kanagawa
TEL 045-261-5656
Email tatsufujiura@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tatsu Fujiura
Organization yokohama city university medical center
Division name rehabilitation division
Zip code
Address 4-57, Urafunecho, Minami-ku, Yokohama-shi, Kanagawa
TEL 045-261-5656
Homepage URL
Email tatsufujiura@gmail.com

Sponsor
Institute yokohama city university medical center
Institute
Department

Funding Source
Organization non
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
Address
Tel
Email

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
2016 Year 01 Month 13 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 07 Day
Last follow-up date
2018 Year 06 Month 30 Day
Date of closure to data entry
2018 Year 07 Month 31 Day
Date trial data considered complete
2018 Year 07 Month 31 Day
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 13 Day
Last modified on
2019 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023648

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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