UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019986 |
|---|---|
| Receipt number | R000023075 |
| Scientific Title | Total knee arthroplasty using custom made template |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2015/12/09 10:17:37 |
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Basic information
Public title
Total knee arthroplasty using custom made template
Acronym
Total knee arthroplasty using custom made template
Scientific Title
Total knee arthroplasty using custom made template
Scientific Title:Acronym
Total knee arthroplasty using custom made template
Region
| Japan |
Condition
Condition
Hemophilic arthropathy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to establish a safe surgical procedure of total knee arthroplasty for a patient with severe joint deformity induced by hemophilic arthropathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The accuracy of implant position is evaluated using CT after surgery.
Key secondary outcomes
Physical examination, radiographic evaluation and patient satisfaction using 2011 knee society scoring system are performed at 6 weeks, 3 months, 6 months, 12 months and once a year since 12 months.
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 |
Interventions/Control_1
Custom made template is used just once for bone resection.
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
Patients with bone malformation or severe deformity which are not applicable conventional bone resection guide.
Key exclusion criteria
Cases that can not create the custom made template from CT or MRI information.
Cases who can not be used custom made template due to intra-operative incompatibility.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Sairyo |
Organization
Tokushima University Graduate School
Division name
Department of Orthopedics
Zip code
Address
3-18-15 Kuramoto Tokushima
TEL
088-633-7240
sairyokun@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Hamada |
Organization
Tokushima University Hospital
Division name
Department of Orthopedics
Zip code
Address
3-18-15 Kuramoto Tokushima
TEL
088-633-7240
Homepage URL
daisuke.hamada@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Graduate School
Department of Orthopedics
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Graduate School
Department of Orthopedics
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
| 2015 | Year | 12 | 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
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
Preinitiation
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | 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
| 2015 | Year | 11 | Month | 29 | Day |
Last modified on
| 2015 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023075
