UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of factors affecting return to work after orthopedic surgery and preliminary study of intervention
Acronym	Investigation of factors affecting return to work after orthopedic surgery and preliminary study of intervention
Scientific Title	Investigation of factors affecting return to work after orthopedic surgery and preliminary study of intervention
Scientific Title:Acronym	Investigation of factors affecting return to work after orthopedic surgery and preliminary study of intervention
Region	Japan

Condition
Condition	patients after orthopedic surgery
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate factors associated with return to work after orthopedic surgery and to evaluate the effectiveness of intervention
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	rate of return to work patients' satisfaction
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group Patient education by physical therapist; exercise therapy and proper posture guidance regarding return to work Historical Control group No intervention
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	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who met the following criteria were included in the study: (1) aged 20-75 years, (2) wish to return to work after surgery (3) undergo orthopedic surgery at our hospital
Key exclusion criteria	Exclusion criteria were (1) unable to obtain informed consent (2) difficult to participate in the current study due to medical reasons other than orthopedic surgery (3) Others; Unsuitable cases judged by physician
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Kitaguchi
Organization	Osaka Rosai Hospital
Division name	Department of Rehabilitation
Zip code	591-8025
Address	1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka 591-8025, Japan
TEL	072-252-3561
Email	takusakimiyu@gmail.com

Public contact
Name of contact person	1st name Takuya Middle name Last name Kitaguchi
Organization	Osaka Rosai Hospital
Division name	Department of Rehabilitation
Zip code	591-8025
Address	1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka 591-8025, Japan
TEL	072-252-3561
Homepage URL
Email	takusakimiyu@gmail.com

Sponsor
Institute	Japan Organization of Occupational Health and Safety
Institute
Department

Funding Source
Organization	Japan Organization of Occupational Health and Safety
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	Osaka Rosai Hospital
Address	1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka 591-8025, Japan
Tel	072-252-3561
Email	takusakimiyu@gmail.com

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	2020 Year 02 Month 25 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	Preinitiation
Date of protocol fixation	2020 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date	2020 Year 04 Month 01 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

Management information
Registered date	2020 Year 02 Month 22 Day
Last modified on	2020 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045124