UMIN-CTR Clinical Trial

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