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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033879
Receipt No. R000038640
Scientific Title Effects of physical therapy on the postoperative day for deep vein thrombosis on patients who had the Total Knee Arthroplasty: Randomized Controlled Trial
Date of disclosure of the study information 2018/08/24
Last modified on 2018/08/24

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Basic information
Public title Effects of physical therapy on the postoperative day for deep vein thrombosis on patients who had the Total Knee Arthroplasty: Randomized Controlled Trial
Acronym Effects of physical therapy on the postoperative day on patients who had the artificial total knee joint placement
Scientific Title Effects of physical therapy on the postoperative day for deep vein thrombosis on patients who had the Total Knee Arthroplasty: Randomized Controlled Trial
Scientific Title:Acronym Effects of physical therapy on the postoperative day on patients who had the artificial total knee joint placement
Region
Japan

Condition
Condition Knee Osteoarthritis
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Total Knee Arthroplasty (TKA) carries a high risk of deep vein thrombosis (DVT).
Some studies have reported that the lower leg massage and passive ankle joint movement during and right after surgery of total hip arthroplasty prevents development of DVT. However, there have been no reports that DVT is prevented by physical therapy bedside on the postoperative day after TKA. The purpose of this study is to clarify the effects of PT care [maximum lower limb elevation, lower leg massage and passive ankle joint movement] on the postoperative day after TKA.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prevalence of DVT (Ultrasonic echo)
Key secondary outcomes Knee pain(Numerical Rating Scale)
With or without Occurrence of subjective symptoms(Mood discomfort,dizziness,nausea)
With or without of embolism

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 PT care[maximum lower limb elevation, lower leg massage and passive ankle joint movement]
Only once,20 minutes,on the day after surgery


Standard protocol(intermittent air compressor)
Only once,the day after surgery through the next day,15 straight hours
Interventions/Control_2 Standard protocol(intermittent air compressor)
Only once,the day after surgery through the next day,15 straight hours
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
55 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Osteoarthritis
Primary surgery
Unilateral or bilateral surgery
Persons until 14 o'clock back to room after surgery
Key exclusion criteria Severe cardiovascular or nervous system disease
Musculoskeletal disorder
Anticoagulation therapy before surgery
Preoperative D-dimer value is 1.0 micrograms/ml or more
With DVT on preoperative and immediately after surgery
History of DVT
Cognitive disease
Target sample size 84

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryo Takahashi
Organization Sonodakai Joint Replacement Center Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-21-10, Hokima, Adachi, Tokyo
TEL 03-5831-1811
Email r_takahashi@sonodakai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Takahashi
Organization Sonodakai Joint Replacement Center Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-21-10, Hokima, Adachi, Tokyo
TEL 03-5831-1811
Homepage URL
Email r_takahashi@sonodakai.or.jp

Sponsor
Institute Sonodakai Joint Replacement Center Hospital
Institute
Department

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
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
2018 Year 08 Month 24 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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 24 Day
Last modified on
2018 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038640

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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