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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044466
Receipt No. R000050796
Scientific Title The relationship between postoperative short-term outcome and self-efficacy in patients after total knee arthroplasty
Date of disclosure of the study information 2021/06/09
Last modified on 2021/06/08

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Basic information
Public title The relationship between postoperative short-term outcome and self-efficacy in patients after total knee arthroplasty
Acronym The relationship between postoperative short-term outcome and self-efficacy in patients after total knee arthroplasty
Scientific Title The relationship between postoperative short-term outcome and self-efficacy in patients after total knee arthroplasty
Scientific Title:Acronym The relationship between postoperative short-term outcome and self-efficacy in patients after total knee arthroplasty
Region
Japan

Condition
Condition Knee osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether psychological factors, such as self-efficacy, as well as physical function and pain, are associated with postoperative outcomes after TKA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The evaluation period is preoperative (one day before surgery) and 3 months after TKA.
The main outcome is the Knee injury and Osteoarthritis Outcome Score (KOOS), a health-related quality of life assessment.
The other outcomes are the modified gait efficacy scale for self-efficacy, Pain catastrophizing scale for catastrophic thinking, rest pain and walking pain, the range of motion of the knee joint in flexion and extension, Isometric knee extension strength (IKES), and walking speed.
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 inclusion criteria were the ability to ambulatory or with T-cane at the time of preoperative evaluation.
Key exclusion criteria Exclusion criteria those with TKA under the diagnosis of idiopathic osteonecrosis and rheumatoid arthritis, Revision of TKA, those with a diagnosis of psychiatric disorder.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yuya
Middle name
Last name Mawarikado
Organization Kashiba Asahigaoka Hospital
Division name Department of rehabilitation
Zip code 639-0265
Address 839 Kaminaka, Kashiba-city, Nara, Japan
TEL 0745778101
Email b9972384@kio.ac.jp

Public contact
Name of contact person
1st name Yuya
Middle name
Last name Mawarikado
Organization Kashiba Asahigaoka Hospital
Division name Department of rehabilitation
Zip code 639-0265
Address 839 Kaminaka, Kashiba-city, Nara, Japan
TEL 0745778101
Homepage URL
Email b9972384@kio.ac.jp

Sponsor
Institute Kashiba Asahigaoka Hospital
Institute
Department

Funding Source
Organization Nara Medical University
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kashiba Asahigaoka Hospital
Address 839 Kaminaka, Kashiba-city, Nara, Japan
Tel 0745778101
Email b9972384@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
2021 Year 06 Month 09 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 120
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 No longer recruiting
Date of protocol fixation
2019 Year 03 Month 01 Day
Date of IRB
2019 Year 05 Month 01 Day
Anticipated trial start date
2019 Year 05 Month 15 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Data collected during the period to March 31, 2022, will used as a prospective study.

Management information
Registered date
2021 Year 06 Month 08 Day
Last modified on
2021 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050796

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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