UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018689 |
|---|---|
| Receipt number | R000021632 |
| Scientific Title | Randomized prospective study in opening wedge high tibial osteotomy with and without navigation system |
| Date of disclosure of the study information | 2015/08/17 |
| Last modified on | 2017/08/21 08:26:42 |
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Basic information
Public title
Randomized prospective study in opening wedge high tibial osteotomy with and without navigation system
Acronym
Opening wedge high tibial osteotomy with and without navigation system
Scientific Title
Randomized prospective study in opening wedge high tibial osteotomy with and without navigation system
Scientific Title:Acronym
Opening wedge high tibial osteotomy with and without navigation system
Region
| Japan |
Condition
Condition
Knee osteoarthritis and knee osteonecrosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients were assigned at random to receive conventional or navigated opening wedge high tibial osteotomy. To evaluate results on radiograph and CT and clinical scores between both groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Results on radiograph and CT and clinical scores between both groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Navigation system
Interventions/Control_2
Conventional method
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with knee osteoarthritis and knee osteonecrosis
Key exclusion criteria
Flexion contructure of more than 20 degree
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Akamatsu |
Organization
Yokohama City University School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2655
akamatsu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Akamatsu |
Organization
Yokohama City University School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2655
Homepage URL
akamatsu@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | 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 | 08 | Month | 16 | Day |
Last modified on
| 2017 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021632
