UMIN-CTR Clinical Trial

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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