UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021627
Receipt number R000024942
Scientific Title Prospective randomized comparison of clinical results between two types of intraoperative body position in total hip arthroplasty.
Date of disclosure of the study information 2016/05/01
Last modified on 2022/03/31 09:07:15

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Basic information

Public title

Prospective randomized comparison of clinical results between two types of intraoperative body position in total hip arthroplasty.

Acronym

Comparison of clinical results between two types of intraoperative body position in total hip arthroplasty.

Scientific Title

Prospective randomized comparison of clinical results between two types of intraoperative body position in total hip arthroplasty.

Scientific Title:Acronym

Comparison of clinical results between two types of intraoperative body position in total hip arthroplasty.

Region

Japan


Condition

Condition

Patients with unilateral total hip arthroplasty, osteoarthritis of the hip

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare clinical results between two types of intraoperative body position in total hip arthroplasty.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Postoperative clinical results

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

An unilateral total hip arthroplasty

Interventions/Control_2

The choice of two types of body position in total hip arthroplasty is randomized.

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 receiving unilateral total hip arthroplasty.

Key exclusion criteria

Exclusion criteria of the patients are as follows.
(1) Patients lacking ability to agree or ability to express agreement for participation appropriately in this study.
(2) Severe contracture of the hip

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Ryohei
Middle name
Last name Takada

Organization

Medical Hospital, Tokyo Medical and Dental University

Division name

Department of orthopedic surgery

Zip code

113-8519

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

TEL

0358035279

Email

takada.orth@tmd.ac.jp


Public contact

Name of contact person

1st name Ryohei
Middle name
Last name Takada

Organization

Medical Hospital, Tokyo Medical and Dental University

Division name

Department of orthopedic surgery

Zip code

113-8519

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

TEL

0358035279

Homepage URL


Email

takada.orth@tmd.ac.jp


Sponsor or person

Institute

Department of Orthopedic Surgery , Medical Hospital, Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

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

Tokyo Medical and Dental University Hospital

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

Tel

03-3813-6111

Email

takada.orth@tmd.ac.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

2016 Year 05 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

30

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

Completed

Date of protocol fixation

2016 Year 03 Month 01 Day

Date of IRB

2016 Year 03 Month 01 Day

Anticipated trial start date

2016 Year 05 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 03 Month 26 Day

Last modified on

2022 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024942


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name