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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043837
Receipt No. 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

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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
Institute Asahikawa Medical University
Department of orthopaedic surgery
Institute
Department

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
URL(English) https://upload.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


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