UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of physical therapy on the postoperative day for deep vein thrombosis on patients who had the Total Knee Arthroplasty: Randomized Controlled Trial
Title of the study (Brief title)	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	Ryo Takahashi
Organization	Sonodakai Joint Replacement Center Hospital
Division name	Department of Rehabilitation Medicine
Address	1-21-10, Hokima, Adachi, Tokyo
TEL	03-5831-1811
Email	r_takahashi@sonodakai.or.jp

Public contact
Name of contact person	Ryo Takahashi
Organization	Sonodakai Joint Replacement Center Hospital
Division name	Department of Rehabilitation Medicine
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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