UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043837
Receipt number R000048532
Scientific Title An Improved Version of Simple Angle-Measuring Instrument for Measuring Cemented Stem Anteversion during Total Hip Arthroplasty
Date of disclosure of the study information 2021/04/08
Last modified on 2021/04/09 16:31:52

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Basic information

Public title

An Improved Version of Simple Angle-Measuring Instrument for Measuring Cemented Stem Anteversion during Total Hip Arthroplasty

Acronym

An Improved Version of Simple Angle-Measuring Instrument for Measuring Cemented Stem Anteversion during Total Hip Arthroplasty

Scientific Title

An Improved Version of Simple Angle-Measuring Instrument for Measuring Cemented Stem Anteversion during Total Hip Arthroplasty

Scientific Title:Acronym

An Improved Version of Simple Angle-Measuring Instrument for Measuring Cemented Stem Anteversion during Total Hip Arthroplasty

Region

Japan


Condition

Condition

osteoarthritis, osteonecrosis of the head, rapidly destructive coxarthrosis, rheumatoid arthritis, and femoral neck fracture

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study was to investigate the accuracy of intraoperative measurements of cemented stem anteversion obtained using the improved version of angle-measuring instrument, compared with a conventional angle-measuring instrument.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

measurements of stem anteversion

Key secondary outcomes

surgical time, amount of bleeding, Harris hip score, HOOS, complications


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Measurement accuracy was defined as the difference between the intraoperative measurements of stem anteversion obtained using the conventional or improved version of instrument and the postoperative measurements of stem anteversion obtained using postoperative CT. We compare the measurement accuracy in same patient using the conventional or improved version of instrument. Implantation accuracy was defined as the difference between the target stem anteversion using improved version of instrument and the postoperative measurements of stem anteversion obtained using postoperative CT. Intervention period is intraoperative period. We observe the intervention group for 6 months. Control group is the patient that reported previously using conventional instrument. We compare the measurement accuracy in patient using the conventional instrument and improved version of instrument.

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 following were required: primary THA, age of 20 years or older, a willingness to participate,

Key exclusion criteria

Exclusion criteria included revision THA, prior hip surgery, infection, bone defect, metabolic bone disease, contraindications for the use of instrument or other conditions judged to be inadequate for participation in this analysis.

Target sample size

149


Research contact person

Name of lead principal investigator

1st name Ryo
Middle name
Last name Mitsutake

Organization

Asahikawa Medical University

Division name

Department of orthopaedic surgery

Zip code

078-8510

Address

Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido

TEL

0166682511

Email

mitutake@asahikawa-med.ac.jp


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Mitsutake

Organization

Asahikawa Medical University

Division name

Department of orthopaedic surgery

Zip code

078-8510

Address

Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido

TEL

0166682511

Homepage URL


Email

mitutake@asahikawa-med.ac.jp


Sponsor or person

Institute

Asahikawa Medical University
Department of orthopaedic surgery

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Asahikawa Medical University

Address

Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido

Tel

0166-68-2297

Email

rs-kk.g@asahikawa-med.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

2021 Year 04 Month 08 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

2021 Year 12 Month 24 Day

Date of IRB

2020 Year 12 Month 24 Day

Anticipated trial start date

2021 Year 04 Month 08 Day

Last follow-up date

2024 Year 12 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

2021 Year 04 Month 04 Day

Last modified on

2021 Year 04 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048532


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name