UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017483 |
|---|---|
| Receipt number | R000020265 |
| Scientific Title | Accuracy of Patient Specific Instrumentation in Total Knee Arthroplasty |
| Date of disclosure of the study information | 2015/05/11 |
| Last modified on | 2022/11/14 10:34:45 |
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Basic information
Public title
Accuracy of Patient Specific Instrumentation in Total Knee Arthroplasty
Acronym
Accuracy of Patient Specific Instrumentation in Total Knee Arthroplasty
Scientific Title
Accuracy of Patient Specific Instrumentation in Total Knee Arthroplasty
Scientific Title:Acronym
Accuracy of Patient Specific Instrumentation in Total Knee Arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accuracy of patient specific instrumentation in total knee arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
accuracy of postoperative alignment
accuracy of the intraoperative registration
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 |
Interventions/Control_1
Use the patient specific instrumentation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients with osteoarthritis or rheumatoid arthritis who are need total knee arthroplasty
Key exclusion criteria
the patients with with inflammatory disease, trauma nor surgical history
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Okazaki |
Organization
Kyushu University
Division name
Department of Orthopaedic Surgery
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5488
okazaki@ortho.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Mizu-uchi |
Organization
Kyushu University
Division name
Department of Orthopaedic Surgery
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5488
Homepage URL
himizu@ortho.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
none
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
Center for Clinical and Translational Research of Kyushu University Hospital
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel
092-642-5774
tr-info@med.kyushu-u.ac.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
| 2015 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/28888738/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/28888738/
Number of participants that the trial has enrolled
18
Results
Article was published
Results date posted
| 2022 | Year | 11 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
18 knees
Participant flow
no problem
Adverse events
none
Outcome measures
radiological outcome
functional outcome
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 10 | Day |
Last modified on
| 2022 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020265
