UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011342 |
|---|---|
| Receipt number | R000013292 |
| Scientific Title | Evaluation of the treatment for osteonecrosis of the femoral head |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2020/02/05 10:54:32 |
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Basic information
Public title
Evaluation of the treatment for osteonecrosis of the femoral head
Acronym
Evaluation of the treatment for osteonecrosis of the femoral head
Scientific Title
Evaluation of the treatment for osteonecrosis of the femoral head
Scientific Title:Acronym
Evaluation of the treatment for osteonecrosis of the femoral head
Region
| Japan |
Condition
Condition
osteonecrosis of the femoral head
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the treatment of the osteonecrosis (THA or BHA),and investigate the differences of the clinical and radiographic parameters between THA and BHA
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
clinical evaluation(pre-operative,post-operative(6months,1year,2year))
Key secondary outcomes
radiographic and functional evaluation,QOL of the patients,complication etc
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients performed THA for the osteonecrosis
Interventions/Control_2
Patients performed BHA for the osteonecrosis
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients enable to perform THA and BHA ,with agreement of the study and follow up.
Key exclusion criteria
The patients experienced past infection
or obesity(BMI>40)
or the patients who is pregnant
or the patients of neuromuscler/sensory nerve desease
or the patients with the history of disease that affects the entire body
or the inadequacy patients judged by the doctor
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukiharu Hasegawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Hip and Knee Reconstructive Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-741-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
Homepage URL
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Stryker Japan
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 08 | Month | 01 | 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
Not Registered
Results date posted
| 2020 | Year | 02 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Not Registered
Participant flow
Not Registered
Adverse events
Not Registered
Outcome measures
Not Registered
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 01 | Day |
Last modified on
| 2020 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013292
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
