UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040825 |
|---|---|
| Receipt number | R000046605 |
| Scientific Title | A new protocol of early rehabilitation after unilateral primary total hip arthroplasty |
| Date of disclosure of the study information | 2020/06/20 |
| Last modified on | 2020/06/18 19:08:44 |
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Basic information
Public title
A new protocol of early rehabilitation after unilateral primary total hip arthroplasty
Acronym
A new protocol of early rehabilitation after unilateral primary total hip arthroplasty
Scientific Title
A new protocol of early rehabilitation after unilateral primary total hip arthroplasty
Scientific Title:Acronym
A new protocol of early rehabilitation after unilateral primary total hip arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis of hip joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the validity of the new protocol for rehabilitation after unilateral primary total hip arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hospital stay after total hip arthroplasy
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Rihabilitation after total hip arthroplasty during hospital stay.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients for unilateral primary total hip arthroplasty
Key exclusion criteria
(1)consciousness disorder
(2)mental disorder
(3)dislocation after the surgery
(4)periprosthetic infection
(5)motor paralysis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Chiba |
Organization
Department of Orthopaedic Surgery, Graduate School of Medicine Tohoku University
Division name
Orthopaedic Surgery
Zip code
9808547
Address
1-1 Seiryomachi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7245
d-chiba@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Chiba |
Organization
Department of Orthopaedic Surgery, Graduate School of Medicine Tohoku University
Division name
Orthopaedic Surgery
Zip code
9808547
Address
1-1 Seiryomachi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7245
Homepage URL
d-chiba@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Graduate School of Medicine Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Graduate School of Medicine Tohoku University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2020 | Year | 06 | Month | 20 | 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 | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | 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 | 06 | Month | 18 | Day |
Last modified on
| 2020 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046605
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
