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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047700
Receipt No. 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

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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
Email 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
Email sk.ymbadc@gmail.com

Sponsor
Institute Shuto General Hospital
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054385

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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