UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022961
Receipt number R000026405
Scientific Title New Predictors for Screw Cutout in Intertrochanteric Hip Fractures Treated by Short Femoral Nail: a multicenter cohort study
Date of disclosure of the study information 2016/06/30
Last modified on 2018/05/15 11:25:05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

New Predictors for Screw Cutout in Intertrochanteric Hip Fractures Treated by Short Femoral Nail: a multicenter cohort study

Acronym

NPSC study

Scientific Title

New Predictors for Screw Cutout in Intertrochanteric Hip Fractures Treated by Short Femoral Nail: a multicenter cohort study

Scientific Title:Acronym

NPSC study

Region

Japan


Condition

Condition

Intertrochanteric hip fracture

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purposes of this study are to quantify screw position in femoral head, to examine whether our new predictor can predict screw cutout, and to compare the new predictor and Tip-apex distance through X-ray images.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Presence or absence of screw cutout within 3 months (12 weeks).

Key secondary outcomes

1) The main surgeon's diagnosis of high risk sign of screw cutout
2) The pre/post-op change of modified Harris hip score


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

Patients diagnosed with intertrochanteric femoral fracture and who agree to participate in this study

Key exclusion criteria

1) patients who do not undergo surgery
2) patients on whom short femoral nail is not used
3) patients who suffer any other fracture together with intertrochanteric femoral fracture
4) patients who had suffered any other fracture within 6 months prior to intertrochanteric femoral fracture
5) patients whose X-ray photography is insufficient to evaluate the indexes because of obscureness or overlap of screw and intramedullary nail

Target sample size

212


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidemi Kawaji

Organization

Nippon Medical School

Division name

Orthopedic Surgery

Zip code


Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan

TEL

03-3822-2131

Email

npsc-admin@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoya Hoshikawa

Organization

Nippon Medical School

Division name

Orthopedic Surgery

Zip code


Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan

TEL

03-3822-2131

Homepage URL


Email

npsc-admin@umin.ac.jp


Sponsor or person

Institute

Nippon Medical School Orthopedic Surgery

Institute

Department

Personal name



Funding Source

Organization

Nippon Medical School Orthopedic Surgery

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


Address


Tel


Email



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

日本医科大学付属病院(東京都)/Nippon Medical School Hospital
日本医科大学武蔵小杉病院(神奈川県)/Nippon medical school Musashi Kosugi Hospital
日本医科大学多摩永山病院(東京都)/Nippon Medical School Tama Nagayama Hospital
日本医科大学千葉北総病院(千葉県)/Nippon Medical School Chiba Hokusoh Hospital
金町中央病院(東京都)/Kanamachi Central Hospital
北村山公立病院(山形県)/Kitamurayama Hospital


Other administrative information

Date of disclosure of the study information

2016 Year 06 Month 30 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

Open public recruiting

Date of protocol fixation

2016 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2016 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Evaluation points are information from medical interview before- and more than 3 months after operation, treatment progress, and findings and indexes from X-ray photographs (anteroposterior, axial and Lauenstein views) before and after operation. Patients are treated with ITST nail.

Medical interviews are performed by the main surgeon. Findings and Indexes from X-ray photographs are checked by 3 orthopedic surgeons as patients' information is blinded.

Indexes are Tip-apex distance (TAD) and new predictors which include inferior distance (ID), Tip-Cortex distance (TCD), anterior distance (AD), and variables which combine ID, TCD and AD.

ID is the shortest distance from tip of lag screw to femoral neck axis in anteroposterior view. AD is also the shortest distance from tip of lag screw to femoral neck axis in the axial and Lauenstein views. ID is a negative value when tip of lag screw is placed proximal of femoral neck axis. Similarly, AD is a negative value when tip of lag screw is placed posterior of femoral neck axis.

TCD is the distance from tip of lag screw to intersection of extension of a lag screw axis and the femoral head cortex. TCD is measured in the anteroposterior, axial and Lauenstein views.

ID, AD, and TCD are calibrated in accordance with the diameter of lag screw, in the same way as TAD.


Management information

Registered date

2016 Year 06 Month 30 Day

Last modified on

2018 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026405


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name