UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047553 |
|---|---|
| Receipt number | R000054099 |
| Scientific Title | Relationship between Preoperative Psychosocial Factors and Postoperative Quality of Life and Satisfaction in Total Knee Arthroplasty Patients -A Longitudinal Study in Japanese Subjects |
| Date of disclosure of the study information | 2022/04/21 |
| Last modified on | 2024/07/16 19:42:27 |
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Basic information
Public title
Relationship between Preoperative Psychosocial Factors and Postoperative Quality of Life and Satisfaction in Total Knee Arthroplasty Patients -A Longitudinal Study in Japanese Subjects
Acronym
Relationship between Preoperative Psychosocial Factors and Postoperative Quality of Life and Satisfaction in Total Knee Arthroplasty Patients -A Longitudinal Study in Japanese Subjects
Scientific Title
Relationship between Preoperative Psychosocial Factors and Postoperative Quality of Life and Satisfaction in Total Knee Arthroplasty Patients -A Longitudinal Study in Japanese Subjects
Scientific Title:Acronym
Relationship between Preoperative Psychosocial Factors and Postoperative Quality of Life and Satisfaction in Total Knee Arthroplasty Patients -A Longitudinal Study in Japanese Subjects
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A multicenter study will be conducted to examine whether preoperative psychosocial factors are a relevant factor in postoperative quality of life and postoperative satisfaction after TKA surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate SF-12 and postoperative satisfaction at 3, 6, and 12 months postoperatively.
Key secondary outcomes
1) Age
2) Gender
3) Body mass index
4)Complications (back pain lasting more than 3 months, hypertension, pulmonary disease, diabetes mellitus)
5)Kellgren-Lawrence classification
6)Pre- and postoperative rehabilitation
7)Final education(middle school graduate, high school graduate, vocational/junior college graduate, university graduate, graduate school graduate (master's degree or higher))
8)Social support
9)Knee joint range of motion
10)CS-30
11)Arthritis Self-Efficacy Scale Japanese 8-item version
12)Pain Catastrophizing Scale Japanese version
13)Hospital Anxitey Depression Scale
14)Brief Fear of Movement Scale for Osteoarthritis
15)Knee injury Osteoarthritis Outcome Score*Excluding sports
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
1)Patients diagnosed with osteoarthritis of the knee and undergoing TKA
2)Those who are able to walk independently or with the use of a T-shaped cane before surgery
Key exclusion criteria
1)Persons diagnosed with rheumatoid arthritis and idiopathic osteonecrosis and undergoing TKA
2)Replacement Example
3)Example of bilateral simultaneous replacement
4)Example of opposite side replacement
5)Those with bone tumors in the lower extremities
6)Persons for whom the physiotherapist in charge judges that it is difficult to conduct the questionnaire due to problems with cognitive function, etc
7)Those with lower limb pain or conditions affecting joint function other than osteoarthritis of the knee.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Koki |
| Middle name | |
| Last name | Santo |
Organization
Kio University Graduate School
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2 Umaminaka, koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL
0745-54-1601
f2965113@kio.ac.jp
Public contact
Name of contact person
| 1st name | Koki |
| Middle name | |
| Last name | Santo |
Organization
Kio University Graduate School
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2 Umaminaka, koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL
0745-54-1601
Homepage URL
f2965113@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
1)Shimada Hospital
2)Japanese Red Cross Kobe Hospital
3)Kobe City Medical Center General Hospital
4)Chuno Kousei Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umaminaka, koryo-cho, Kitakatsuragi-gun, Nara, Japan
Tel
0745-54-1601
f2965113@kio.ac.jp
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
| 2022 | Year | 04 | Month | 21 | 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
| 2022 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none in particular.
Management information
Registered date
| 2022 | Year | 04 | Month | 21 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054099
