UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047700 |
|---|---|
| Receipt number | R000054385 |
| Scientific Title | Open label randomized parallel group comparison trial of short nail and middle nail with open osteosynthesis for unstable trochanteric fractures |
| Date of disclosure of the study information | 2022/05/10 |
| Last modified on | 2022/05/10 16:55:05 |
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Basic information
Public title
Randomized controlled trial of open osteosynthesis for unstable trochanteric fractures
Acronym
ROUT Study
Scientific Title
Open label randomized parallel group comparison trial of short nail and middle nail with open osteosynthesis for unstable trochanteric fractures
Scientific Title:Acronym
ROUT Study
Region
| Japan |
Condition
Condition
unstable trochanteric fractures
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It still remains inconclusive whether SFN or MFN is more efficient in osteosynthesis for unstable trochanteric fractures.
The purpose of this study is to compare the effects from nail length on the clinical and radiographical outcomes in osteosynthesis for unstable trochanteric fractures with short nail versus middle nail.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Maintenance rate of the reduction position at 3 months postoperatively.
Key secondary outcomes
Length of telescoping and status of bone fusion on x-ray at 3 weeks and 3 months postoperatively.
NRS, BI, FIM, grip strength, and gait at 3 weeks and 3 months postoperatively.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Open osteosynthesis using short nails for unstable trochanteric fractures.
Interventions/Control_2
Open osteosynthesis using middle nails for unstable trochanteric fractures.
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
Patient with a first time trochanteric fracture and classified as unstable on imaging evaluation.
Patients who have been fully informed and have given written consent to participate in this study.
Key exclusion criteria
Patients for whom long nails, artificial head replacement, etc. are considered appropriate.
Patients who have difficulty with postoperative imaging evaluation.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shotaro |
| Middle name | |
| Last name | Kawano |
Organization
Shuto General Hospital
Division name
Orthopecics
Zip code
742-0032
Address
1000-1 Kokaisaku, Yanai City, Yamaguchi Prefecture,Japan.
TEL
0820-22-3456
sk.ymbadc@gmail.com
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Kawano |
Organization
Shuto General Hospital
Division name
Orthopedics
Zip code
742-0032
Address
1000-1 Kokaisaku, Yanai City, Yamaguchi Prefecture,Japan.
TEL
0820-22-3456
Homepage URL
sk.ymbadc@gmail.com
Sponsor or person
Institute
Shuto General Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
Shuto General Hospital Ethics Review Committee
Address
1000-1 Kokaisaku, Yanai City, Yamaguchi Prefecture,Japan.
Tel
0820-22-3456
ykura@hsp-shuto.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
周東総合病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2022 | Year | 05 | Month | 10 | Day |
Last modified on
| 2022 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054385
| Research Plan | |
|---|---|
| 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 |
