UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015360 |
|---|---|
| Receipt number | R000017832 |
| Scientific Title | Comparison of clinical outcome of total knee arthroplasty associated with CT-free navigation and MRI-based instruments |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2016/11/22 22:31:36 |
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Basic information
Public title
Comparison of clinical outcome of total knee arthroplasty associated with CT-free navigation and MRI-based instruments
Acronym
Comparison of clinical outcome of total knee arthroplasty associated with CT-free navigation and MRI-based instruments
Scientific Title
Comparison of clinical outcome of total knee arthroplasty associated with CT-free navigation and MRI-based instruments
Scientific Title:Acronym
Comparison of clinical outcome of total knee arthroplasty associated with CT-free navigation and MRI-based instruments
Region
| Japan |
Condition
Condition
osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare accuracy of CT-free navigation and MRI-based instruments for total knee arthroplasty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Knee Society Score
Key secondary outcomes
Knee joint range of motion,Villalta scale, Short Form-8,Visual analog Scale(VAS),Knee Injury and Osteoarthritis Outcome Score,and alignment of femoral component and tibial component.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
MRI-based instrument
Interventions/Control_2
CT-free navigation
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
Patients who undergo primary total knee arthroplasty for osteoarthritis of the knee.
Written informed consents are obtained from all the patients.
Key exclusion criteria
Patients who have complications such as interfere with general anesthesia or those that affect knee surgery.
Patients with non-self-walking.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Furumatsu |
Organization
Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Division name
Department of Orthopaedic Surgery
Zip code
Address
2-5-1 Shikata-cho, Kita-ku,Okayama
TEL
086-235-7273
matino@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Furumatsu |
Organization
Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Division name
Department of Orthopaedic Surgery
Zip code
Address
2-5-1 Shikata-cho, Kita-ku,Okayama
TEL
086-235-7273
Homepage URL
matino@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
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
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
| 2014 | Year | 11 | 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
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | 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
| 2014 | Year | 10 | Month | 07 | Day |
Last modified on
| 2016 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017832
