UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032704
Receipt number R000037246
Scientific Title Usefulness of navigation system and three-dimensional finite element analysis for hip surgery
Date of disclosure of the study information 2018/05/24
Last modified on 2018/05/24 18:04:57

* 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

Usefulness of navigation system and three-dimensional finite element analysis for hip surgery

Acronym

Usefulness of navigation system and three-dimensional finite element analysis for hip surgery

Scientific Title

Usefulness of navigation system and three-dimensional finite element analysis for hip surgery

Scientific Title:Acronym

Usefulness of navigation system and three-dimensional finite element analysis for hip surgery

Region

Japan


Condition

Condition

hip disease

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate the accuracy and safety of the surgery using navigation system and stress changes due to hip surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The accuracy and safety of the surgery using navigation system and stress in the hip joint analyzed by finite element analysis.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


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

Surgical treatment with navigation.

Interventions/Control_2

Surgical treatment without navigation.

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

Patients with surgical treatment (total hip arthroplasty or hip osteotomy) in the hip joint.

Key exclusion criteria

Informed consent was not obtained.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yutaka Inaba

Organization

Yokohama City University School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code


Address

Fukuura 3-9, Kanazawaku, Yokohama

TEL

045-787-2800

Email

sle9999mds@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroyuki Ike

Organization

Yokohama City University School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code


Address

Fukuura 3-9, Kanazawaku, Yokohama

TEL

045-787-2800

Homepage URL


Email

sle9999mds@yahoo.co.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Yokohama City University

Organization

Division

Category of Funding Organization

Local Government

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



Other administrative information

Date of disclosure of the study information

2018 Year 05 Month 24 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2009 Year 05 Month 08 Day

Date of IRB


Anticipated trial start date

2009 Year 05 Month 08 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 24 Day

Last modified on

2018 Year 05 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037246


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name