UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031158 |
|---|---|
| Receipt number | R000035569 |
| Scientific Title | Clinical outcome of open wedge high tibial osteotomy combined with arthroscopic centralization of an extruded medial meniscus. |
| Date of disclosure of the study information | 2018/02/05 |
| Last modified on | 2019/09/06 19:16:25 |
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Basic information
Public title
Clinical outcome of open wedge high tibial osteotomy combined with arthroscopic centralization of an extruded medial meniscus.
Acronym
Clinical outcome of open wedge high tibial osteotomy combined with arthroscopic centralization of an extruded medial meniscus.
Scientific Title
Clinical outcome of open wedge high tibial osteotomy combined with arthroscopic centralization of an extruded medial meniscus.
Scientific Title:Acronym
Clinical outcome of open wedge high tibial osteotomy combined with arthroscopic centralization of an extruded medial meniscus.
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is the comparison between the clinical outcome of the higher tibial osteotomy with meniscal treatment and without meniscal treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
KOOS: Knee injury and Osteoarthritis Outcome Score,Knee society score,Lysholm score, NRS
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
Arthroscopic centralization of an extruded medial meniscus while the higher tibial osteotomy.
Interventions/Control_2
the higher tibial osteotomy only.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Knee OA
jiont space kissing <1cm
unicompartment OA
meniscus extrusion >3mm or 3mm
Key exclusion criteria
Knee range of motion
flexion angle <120
flexion contracture>10
FTA >190
ACL instability knee
FTA >190
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Katagiri |
Organization
Tokyo Medical and Dental University
Division name
Department of Joint Surgery and Sports Medicine,
Zip code
113-8519
Address
1-5-45 yushima bunkyouku tokyo
TEL
03-5803-4675
katagiri.orj@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Katagiri |
Organization
Tokyo Medical and Dental University
Division name
Department of Joint Surgery and Sports Medicine,
Zip code
113-8519
Address
1-5-45 yushima bunkyouku tokyo
TEL
03-5803-4675
Homepage URL
katagiri.orj@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Donation (1707 Senior Researcher Hideyuki Koga)
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
Tokyo Medical and Dental University Hospital Hospital Clinical Research Review Committee
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4675
katagiri.orj@tmd.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
| 2018 | Year | 02 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2018 | Year | 02 | Month | 05 | Day |
Last modified on
| 2019 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035569
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
