UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020618 |
|---|---|
| Receipt number | R000023799 |
| Scientific Title | Hindfoot alignment after high tibial osteotomy |
| Date of disclosure of the study information | 2016/01/18 |
| Last modified on | 2019/03/05 19:04:57 |
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Basic information
Public title
Hindfoot alignment after high tibial osteotomy
Acronym
Hindfoot alignment after high tibial osteotomy
Scientific Title
Hindfoot alignment after high tibial osteotomy
Scientific Title:Acronym
Hindfoot alignment after high tibial osteotomy
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee, avascular necrosis of the medial femoral condyle
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the improvement of hindfoot alignment after high tibial osteotomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The varus-valgus angle on the wight-bearing X-ray film taken 1 to 1.5 year after high tibial osteotomy.
The varus-valgus angle is defined as the angle between the longitudinal axis of the tibia and the line from the top of the sustentaculum tali to the lateral-inferior end of the calcaneus.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients scheduled for high tibial osteotomy
Key exclusion criteria
History of trauma or surgery around ankle
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sachiyuki Tsukada |
Organization
Nekoyama Miyao Hospital
Division name
Orthopaedic surgery
Zip code
Address
14-7 Konan, Chuo-ku, Niigata, Niigata, 950-1151 Japan
TEL
025-282-2323
s8058@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiyuki Tsukada |
Organization
Nekoyama Miyao Hospital
Division name
Orthopaedic surgery
Zip code
Address
14-7 Konan, Chuo-ku, Niigata, Niigata, 950-1151, Japan
TEL
025-282-2323
Homepage URL
s8058@nms.ac.jp
Sponsor or person
Institute
Nekoyama Miyao Hospital
Institute
Department
Personal name
Funding Source
Organization
Nekoyama Miyao Hospital
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
| 2016 | Year | 01 | Month | 18 | 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
| 2016 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study include the patinets undergoing high tibial osteotomy from January 19 2016 at Nekoyama Miyao Hospital.
Management information
Registered date
| 2016 | Year | 01 | Month | 18 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023799
