UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030335 |
|---|---|
| Receipt number | R000034644 |
| Scientific Title | Portable Navigation vs Conventional Instrument for Total Hip Arthroplasty:Prospective Randomized Trial |
| Date of disclosure of the study information | 2017/12/13 |
| Last modified on | 2021/07/23 14:00:41 |
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Basic information
Public title
Portable Navigation vs Conventional Instrument for Total Hip Arthroplasty:Prospective Randomized Trial
Acronym
Portable Navigation for Total Hip Arthroplasty
Scientific Title
Portable Navigation vs Conventional Instrument for Total Hip Arthroplasty:Prospective Randomized Trial
Scientific Title:Acronym
Portable Navigation for Total Hip Arthroplasty
Region
| Japan |
Condition
Condition
Hip Osteoarthritis, Osteonecrosis of femoral head, Rapidly destructive coxarthropathy, Rhumatoid arthritis, Proximal femoral fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objective is to investigate whether component position is more accurate using portable navigation system of total hip arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Component position
Key secondary outcomes
Factors related with surgery, Postoperative course(six months)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Portable navigation
Interventions/Control_2
Conventional instrument
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
Need for total hip arthroplasty, 20 years or older, Willing to participate
Key exclusion criteria
Neuromuscular disease, Osteomalasia, Severe osteoporosis, Bone metabolic disease, Infection around hip, Severe bone loss, Other conditions judged to be inadequate for participation in the trial
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Tanino |
Organization
Asahikawa Medical University
Division name
Department of Orthopaedic Surgery
Zip code
Address
Midorigaoka Higashi 2-1-1-1, Asahikawa
TEL
0166682512
taninohiromasa@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromasa Tanino |
Organization
Asahikawa Medical University
Division name
Department of Orthopaedic Surgery
Zip code
Address
Midorigaoka Higashi 2-1-1-1, Asahikawa
TEL
0166682512
Homepage URL
taninohiromasa@hotmail.com
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
OrthoAlign
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 12 | Month | 13 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 27 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 27 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 10 | Day |
Last modified on
| 2021 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034644
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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