UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003175 |
|---|---|
| Receipt number | R000003850 |
| Scientific Title | Examination of postoperative change of the artificial bone which used for opening wedge high tibial osteotomy |
| Date of disclosure of the study information | 2010/02/15 |
| Last modified on | 2010/02/12 18:24:57 |
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Basic information
Public title
Examination of postoperative change of the artificial bone which used for opening wedge high tibial osteotomy
Acronym
Examination of postoperative change of the artificial bone which used for opening wedge high tibial osteotomy
Scientific Title
Examination of postoperative change of the artificial bone which used for opening wedge high tibial osteotomy
Scientific Title:Acronym
Examination of postoperative change of the artificial bone which used for opening wedge high tibial osteotomy
Region
| Japan |
Condition
Condition
Medial type osteoarthristi of the knee or ideopathic osteonecrosis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We observe what kind of course an artificial bone is replaced by an aut bone in vivo
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We obtain an artificial bone in postoperative one year.
An artificial bone was stained hematoxyline and eosin, and we reviwed it pathologically.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
We obtain an artificial bone in bone biopsy needle postoperatively.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who did high tibial osteotomy and passed one year.
Key exclusion criteria
There is particularly no it.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kodaira |
Organization
shinshu university
Division name
Rehabiritation part
Zip code
Address
3-1-1 Asahi Matumoto-shi Nagano 390-8621 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
shinshu university school
Division name
Department of orthopaedic surgery
Zip code
Address
TEL
0263-37-2659
Homepage URL
Sponsor or person
Institute
Department of orthopaedic surgery shinshu university school medicine
Institute
Department
Personal name
Funding Source
Organization
Department of orthopaedic surgery shinshu university school medicine
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
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
| 2010 | Year | 02 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 12 | Day |
Last modified on
| 2010 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003850
