UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter Study for Evaluation of Rotational Instability of Femoral Trochanteric Fractures
Acronym	Multicenter Study for Evaluation of Rotational Instability of Femoral Trochanteric Fractures
Scientific Title	Multicenter Study for Evaluation of Rotational Instability of Femoral Trochanteric Fractures
Scientific Title:Acronym	Multicenter Study for Evaluation of Rotational Instability of Femoral Trochanteric Fractures
Region	Japan

Condition
Condition	Femoral Trochanteric Fracture
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to assess the femoral head rotational stability of integrated lag screw compared with single lag screw design of short femoral nail in femoral trochanteric fracture.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rotational angle of femoral head using computer tomography reconstruction images at 3-months post-op.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Short Femoral Nail with an Intergrated Lag Screw
Interventions/Control_2	Short Femoral Nail with a Single Lag Screw
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patient with femoral trochanteric fracuture, (candidate for short femoral nail fixation) 2. AO classification A1 and A2 3. Patient whose written consent was obtained to participate in the study
Key exclusion criteria	1. Adolescent who need a informed assent 2. A patient who may present difficulties of CT analysis due to metal artifacts by metal implantation at proximal femur or other factors 3. Patient ruled unfit to the study by a surgeon
Target sample size	316

Research contact person
Name of lead principal investigator	1st name Toshiyuki Middle name Last name Matsumoto
Organization	Kochi Medical Center
Division name	Department of Orthopaedics
Zip code	7218511
Address	2125-1,Ike, Kochi-shi, Kochi-ken, Japan
TEL	088-837-3000
Email	wohltunimuri@yahoo.co.jp

Public contact
Name of contact person	1st name Ryu Middle name Last name Tamura
Organization	Kochi Medical Center
Division name	Department of Orthopaedics
Zip code	7218511
Address	Department of Orthopaedics
TEL	088-837-3000
Homepage URL
Email	tamuryu_integra_type_r@yahoo.co.jp

Sponsor
Institute	Kochi Medical Center
Institute
Department

Funding Source
Organization	Smith & Nephew Orthopaedics KK
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kagawa Prefectural Central Hospital, Shikoku Medical Center for Children and Adults, Uwajima City Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kochi Health Sciences Center
Address	2125-1 Ike Kochi City Kochi Pref. Japan
Tel	088-837-3682
Email	rinsyo@khsc.or.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	2015 Year 07 Month 29 Day

Related information
URL releasing protocol	https://www2.khsc.or.jp/info/dtl.php?ID=1110
Publication of results	Unpublished

Result
URL related to results and publications	https://www2.khsc.or.jp/info/dtl.php?ID=1110
Number of participants that the trial has enrolled	195
Results	Rotation angle was measured clinically from 0 to 8.1 degree. Dual screw type of implant is recommended to persist rotation of the proximal fragment and center Position of implant is the most important factor to prevent rotation.
Results date posted	2020 Year 06 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Group Dual Single N 103 92 Age　 86.2 84.7 Sex Male 23 21 Female 80 71 AO classification　A1 40 36 　　　　 A2 63 56 CT classification stable 40 35 　　　　 unstable 63 57
Participant flow	Assessed for eligibility (n=263) 　Excluded (n=68) Not Meeting incrusion criteria(n=58) Declined to participate (n=8) Other reasons, dupliaction (n=2) Randomized (n=195) Allocated to Intervention Dual screw (n=103) Lost to follow up (n=16) Analysed (n=87) Allocated to Intervention Single screw (n=92) Lost to follow up (n=18) Analysed (n=74)
Adverse events	There was no complication aboue insertion od PLLA pin.One cut out case was seen in single screw grpou and revision surgery was needed.
Outcome measures	Primary outcome was rotational angle of proximal fragment and its difference between two group and primary end point was occurrence of cutout. Key secondary outcomes were comparison of rotation angle between AO classification A1 or A2, preoperative 3DCT classification, position of implant whether center or decenter, right side of left and amount of the telescoping between two groups. We used IBM SPSS version 19 for statistical Evaluation, and Unpaired t-test and Pearson's correlation coefficient as statistical method.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 24 Day
Date of IRB	2015 Year 03 Month 18 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry	2019 Year 02 Month 28 Day
Date trial data considered complete	2019 Year 03 Month 12 Day
Date analysis concluded	2019 Year 03 Month 20 Day

Other
Other related information

Management information
Registered date	2015 Year 07 Month 14 Day
Last modified on	2021 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021145