UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005579 |
|---|---|
| Receipt number | R000006599 |
| Scientific Title | Clinical application of custom cutting device for total knee arthroplasty |
| Date of disclosure of the study information | 2011/05/10 |
| Last modified on | 2013/11/13 06:33:03 |
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Basic information
Public title
Clinical application of custom cutting device for total knee arthroplasty
Acronym
Clinical application of custom cutting device for total knee arthroplasty
Scientific Title
Clinical application of custom cutting device for total knee arthroplasty
Scientific Title:Acronym
Clinical application of custom cutting device for 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 effectiveness and accuracy of bone cutting with the custom cutting device in total knee replacement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Coronal and rotational alignment of femoral component and tibial component
Key secondary outcomes
Operation time
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intra-operative use of custom cutting device made from the preoperative MRI in addition to normal devices
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo total knee arthroplasty for osteoarthritis
Key exclusion criteria
Patients who cannot undergo MRI
Patients with metal implant around the knee joint
Patints with extra-articular deformity of the lower extremities
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Kashiwaba |
Organization
Tohoku University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
Seiryo1-1, Aoba-ku Sendai, JAPAN 980-8574
TEL
022-717-7245
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Takahashi |
Organization
Tohoku University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
Seiryo1-1, Aoba-ku Sendai, JAPAN 980-8574
TEL
022-717-7245
Homepage URL
Sponsor or person
Institute
Department of Orthopaedic Surgery, Tohoku University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Tohoku University School of 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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 10 | 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
Completed
Date of protocol fixation
| 2011 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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
| 2011 | Year | 05 | Month | 10 | Day |
Last modified on
| 2013 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006599
