UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018307
Receipt number R000021145
Scientific Title Multicenter Study for Evaluation of Rotational Instability of Femoral Trochanteric Fractures
Date of disclosure of the study information 2015/07/29
Last modified on 2021/07/08 11:47:59

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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 or person

Institute

Kochi Medical Center

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021145


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name