UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036301 |
|---|---|
| Receipt number | R000041363 |
| Scientific Title | Comparison of Bone Reaction between Two Type of Stem for the Champange Flute Canal. |
| Date of disclosure of the study information | 2019/03/26 |
| Last modified on | 2019/03/26 20:36:02 |
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Basic information
Public title
Comparison of Bone Reaction between Two Type of Stem for the Champange Flute Canal.
Acronym
Comparison of Bone Reaction between Two Type of Stem for the Champange Flute Canal.
Scientific Title
Comparison of Bone Reaction between Two Type of Stem for the Champange Flute Canal.
Scientific Title:Acronym
Comparison of Bone Reaction between Two Type of Stem for the Champange Flute Canal.
Region
| Japan |
Condition
Condition
Hip Orthoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observe and evaluate the differences in bone response of patients who were inserted two similar shapes of cementless stems.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate bone reaction at 5 years after surgery between both stems and examine differences in appearance of Stress Sheilding
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Employ the Taper Loc Complete Microplasty (Zimmer Biomet)
Interventions/Control_2
Employ the Ovation Tribute (Ortho Development)
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Champange Flute Canal
Key exclusion criteria
over 50 degree of femoral anteversion
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Hirasawa |
Organization
Hokusuikai Kinen Hospital
Division name
Orthopaedic surgery
Zip code
310-0035
Address
3-2-1 Higashihara, Mito, Ibaraki 310-0035, Japan
TEL
0293033003
hirari3@orion.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Hirasawa |
Organization
Hokusuikai Kinen Hospital
Division name
Orthopaedic surgery
Zip code
310-0035
Address
3-2-1 Higashihara, Mito, Ibaraki 310-0035, Japan
TEL
0293033003
Homepage URL
hirari3@orion.ocn.ne.jp
Sponsor or person
Institute
Hokusuikai Kinen Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan MDM
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
Hokusuikai Kinen Hospital
Address
3-2-1 Higashihara, Mito, Ibaraki 310-0035, Japan
Tel
029-303-3003
hakoda@hokusuikai-kinen.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
| 2019 | Year | 03 | Month | 26 | 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
44
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041363
