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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035215
Receipt No. R000040133
Scientific Title Effects of preoperative pain, physical function factors, and psychological factors on postoperative physical activity for total knee arthroplasty
Date of disclosure of the study information 2018/12/12
Last modified on 2018/12/11

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Basic information
Public title Effects of preoperative pain, physical function factors, and psychological factors on postoperative physical activity for total knee arthroplasty
Acronym Preoperative factors influencing postoperative activity after knee arthroplasty
Scientific Title Effects of preoperative pain, physical function factors, and psychological factors on postoperative physical activity for total knee arthroplasty
Scientific Title:Acronym Preoperative factors influencing postoperative activity after knee arthroplasty
Region
Japan

Condition
Condition total knee arthroplasty
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to evaluate the influence of preoperative pain, physical function factors, and psychological factors on postoperative physical activity levels.
Basic objectives2 Others
Basic objectives -Others Apply to clinical management early postoperatively.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes daily step count
Key secondary outcomes

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
60 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria The study included patients who underwent TKA for osteoarthritis from April 2014 to June 2018 in the medical institution to which the first author belongs.
Key exclusion criteria Exclusion criteria were as follows: an inability to understand the objectives of the study due to dementia, mental health disorders, postoperative complications such as nerve injury or deep vein thrombosis, other significant medical diseases which interfered with postoperative rehabilitation, previous TKA (TKA of the opposite limb and revision), and TKA performed for causes other than degenerative diseases (rheumatoid arthritis and bone necrosis).
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Hiraga
Organization Fukuoka Rehabilitation Hospital
Division name Rehabilitation
Zip code
Address 770-7, Nokata, Fukuoka Nishi-ku Fukuoka
TEL 0928121555
Email nokopata_nokopata@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Hiraga
Organization Fukuoka Rehabilitation Hospital
Division name Rehabilitation
Zip code
Address 770-7, Nokata, Fukuoka Nishi-ku Fukuoka
TEL 0928121555
Homepage URL
Email nokopata_nokopata@yahoo.co.jp

Sponsor
Institute Fukuoka Rehabilitation Hospital
Institute
Department

Funding Source
Organization none
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
2018 Year 12 Month 12 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
2014 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information During the research, four participants withdrew, and 139 participants completed the study.

Management information
Registered date
2018 Year 12 Month 11 Day
Last modified on
2018 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040133

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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