UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039570 |
|---|---|
| Receipt number | R000045124 |
| Scientific Title | Investigation of factors affecting return to work after orthopedic surgery and preliminary study of intervention |
| Date of disclosure of the study information | 2020/02/25 |
| Last modified on | 2020/02/22 17:00:16 |
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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
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
takusakimiyu@gmail.com
Sponsor or person
Institute
Japan Organization of Occupational Health and Safety
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045124
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
