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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013131
Receipt No. R000015313
Scientific Title Effect of Adding Twice Series of Multiple Knee Flexion within Two Hours after Surgery to Fast-Track Rehabilitation after Total Knee Arthroplasty in Elderly Patients: A Randomized Trial
Date of disclosure of the study information 2014/02/11
Last modified on 2016/02/23

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Basic information
Public title Effect of Adding Twice Series of Multiple Knee Flexion within Two Hours after Surgery to Fast-Track Rehabilitation after Total Knee Arthroplasty in Elderly Patients: A Randomized Trial
Acronym Adding of knee flexion to fast-track rehabilitation
Scientific Title Effect of Adding Twice Series of Multiple Knee Flexion within Two Hours after Surgery to Fast-Track Rehabilitation after Total Knee Arthroplasty in Elderly Patients: A Randomized Trial
Scientific Title:Acronym Adding of knee flexion to fast-track rehabilitation
Region
Europe

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

Objectives
Narrative objectives1 whether adding of flexion series would improve pain and knee function.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes KSS scores,VAS values, KOOS
Key secondary outcomes

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Twice series of multiple knee flexion within 2 hours after total knee arthroplasty
Interventions/Control_2 patients without any series of knee flexion within 6 hours after surgery
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
18 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria primary osteoarthrosis, adult patients and operated by the same surgeon
Key exclusion criteria Patients are excluded if they are unable to complete the protocol or have rheumatoid arthritis, systemic or metabolic disorders, an American Society of Anesthesiologists (ASA) score of 3, previous major surgery on the affected joint, neurologic or psychiatric disease, or alcohol abuse.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Zietek
Organization Pomeranian Medical University of Szczecin
Division name Orthopaedics
Zip code
Address ul. Unii Lubelskiej 1, Szczecin, Poland
TEL +48914253238
Email paulz@wp.pl

Public contact
Name of contact person
1st name
Middle name
Last name Zietek
Organization Pomeranian Medical University in Szczecin
Division name Orthopaedics
Zip code
Address ul. Unii Lubelskiej 1, Szczecin, Poland
TEL +48914253238
Homepage URL
Email paulz@wp.pl

Sponsor
Institute Pomeranian Medical University in Szczecin
Institute
Department

Funding Source
Organization Self
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
2014 Year 02 Month 11 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 Terminated
Date of protocol fixation
2014 Year 02 Month 11 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 11 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
2014 Year 02 Month 11 Day
Last modified on
2016 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015313

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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