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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003175
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of orthopaedic surgery shinshu university school medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003850

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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