UMIN-CTR Clinical Trial

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	Main results already published
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	2022 Year 10 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050796