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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030335
Receipt No. 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

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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
Email 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
Email taninohiromasa@hotmail.com

Sponsor
Institute Asahikawa Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034644

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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