UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003069
Receipt number R000003716
Scientific Title Hip stability in total hip arthroplasty by the change of the femoral head sizes
Date of disclosure of the study information 2010/01/25
Last modified on 2010/01/20 22:35:06

* 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

Hip stability in total hip arthroplasty by the change of the femoral head sizes

Acronym

Hip stability in total hip arthroplasty by the change of the femoral head sizes

Scientific Title

Hip stability in total hip arthroplasty by the change of the femoral head sizes

Scientific Title:Acronym

Hip stability in total hip arthroplasty by the change of the femoral head sizes

Region

Japan


Condition

Condition

hip osteoarthritis
avascular necrosis of the femoral head
rheumatoid arthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Hip stability in total hip arthroplasty by the change of the femoral head sizes

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

we used goniometer to quantify the effect of change of head sizes on ROM, type of impingement,flexion to dislocation, and displacement to dislocation.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

head size 22mm
head size 28mm
head size 36mm

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

The patient of total hip arthroplasty

Key exclusion criteria

A minor,an insufficient adult of the ability for judgment

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Morioka Susumu

Organization

Shinshu University Hospital

Division name

Orthopaedic Surgery

Zip code


Address

3-1-1 Asahi, Matsumoto-shi,Nagano

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Shinshu University Hospital

Division name

Orthopaedic Surgery

Zip code


Address

3-1-1 Asahi, Matsumoto-shi,Nagano

TEL


Homepage URL


Email



Sponsor or person

Institute

Shinshu University Hospital Orthopaedic Surgery

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

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

2010 Year 01 Month 25 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

2010 Year 01 Month 21 Day

Date of IRB


Anticipated trial start date

2010 Year 01 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



Management information

Registered date

2010 Year 01 Month 20 Day

Last modified on

2010 Year 01 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003716


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name