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
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
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
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
