UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035215 |
|---|---|
| Receipt number | 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 02:24:47 |
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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
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
nokopata_nokopata@yahoo.co.jp
Sponsor or person
Institute
Fukuoka Rehabilitation Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040133
