UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017424 |
|---|---|
| Receipt number | R000020210 |
| Scientific Title | Clinical outcome after open wedge high tibial osteotomy with and without autologous osteophyte graft |
| Date of disclosure of the study information | 2015/05/07 |
| Last modified on | 2015/05/06 05:57:56 |
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Basic information
Public title
Clinical outcome after open wedge high tibial osteotomy with and without autologous osteophyte graft
Acronym
Clinical outcome after open wedge high tibial osteotomy with and without autologous osteophyte graft
Scientific Title
Clinical outcome after open wedge high tibial osteotomy with and without autologous osteophyte graft
Scientific Title:Acronym
Clinical outcome after open wedge high tibial osteotomy with and without autologous osteophyte graft
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the osteoconductivity of autologous osteophyte graft in medial open wedge high tibial
osteotomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Xp,CT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
autologous osteophyte graft
Interventions/Control_2
Non autologous osteophyte graft
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
| 55 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Grade 3 and 4 of medial osteoarthritis ofthe knee using Kellgren-Lawrence classification
Key exclusion criteria
(1) Patients whose lateral femorotibial angle was more than 185 (2) patients who had an extension loss of more than 15,(3) patients who had a history of infection in the knee,(4) patients who had anterior cruciate ligament insufficiency or varus/valgus instability of more than 10
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Kondo |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Advanced Therapeutic Research for Sports Medicine
Zip code
Address
Kita 15 Nishi 7, Kita-ku, Sapporo 0608638, Japan
TEL
011-706-5935
eijik@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Kondo |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Advanced Therapeutic Research for Sports Medicine
Zip code
Address
Kita 15 Nishi 7, Kita-ku, Sapporo 0608638, Japan
TEL
011-706-5935
Homepage URL
eijik@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 07 | 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
| 2013 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | 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
| 2015 | Year | 05 | Month | 06 | Day |
Last modified on
| 2015 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020210
