UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012711 |
|---|---|
| Receipt number | R000014850 |
| Scientific Title | Comparative study of bone formation and remodeling between Hydroxyapatite/collagen composite and Beta TCP filled in the opening wedge after OWHTO-prospective randomized study- |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2019/07/26 08:41:15 |
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Basic information
Public title
Comparative study of bone formation and remodeling between Hydroxyapatite/collagen composite and Beta TCP filled in the opening wedge after OWHTO-prospective randomized study-
Acronym
Comparative study of bone formation and remodeling between Hydroxyapatite/collagen composite and Beta TCP after OWHTO-prospective randomized study-
Scientific Title
Comparative study of bone formation and remodeling between Hydroxyapatite/collagen composite and Beta TCP filled in the opening wedge after OWHTO-prospective randomized study-
Scientific Title:Acronym
Comparative study of bone formation and remodeling between Hydroxyapatite/collagen composite and Beta TCP after OWHTO-prospective randomized study-
Region
| Japan |
Condition
Condition
osteoarthritis of the knee joint, osteonecrosis of the knee joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To know the differences of bone formation, remodeling, and clinical outcomes including JOA (Japanese Orthopedic Association) score for osteoarthritis of the knee joint and JKOM (Japanese Knee Osteoarthritis Measure) between hydroxyapatite/collagen composite and beta-TCP after opening wedge high tibial osteotomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluations of bone formation and remodeling using serial radiographs, and clinical outcome measures including JOA (Japanese Orthopedic Association) score for osteoarthritis of the knee joint and JKOM (Japanese Knee Osteoarthritis Measure)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Hydroxyapatite/collagen composite (ReFit, Hoya corp.Tokyo, Japan) group
Interventions/Control_2
beta-TCP (OSferion, Olympus Terumo Biomaterial Corp. Tokyo, Japan) group
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
The patients who agree for participation in this study , were undergone opening wedge HTO, and also were able to followed-up more than a year after the operation.
Key exclusion criteria
The patients whose postoperative course was significantly different from the ordinary course because of the other reasons of the side effects including breakage of fixation device.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsuto |
| Middle name | |
| Last name | Hoshikawa |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Orthopaedic Surgery
Zip code
3508550
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
+81-49-228-3627
hiraoka@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Atsuto |
| Middle name | |
| Last name | Hoshikawa |
Organization
Saitama Medical Centre, Saitama Medical University
Division name
Department of Orthopaedic Surgery
Zip code
3508550
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
+81-49-228-3627
Homepage URL
hiraoka@saitama-med.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
non
Name of secondary funder(s)
non
IRB Contact (For public release)
Organization
Institutional Review Board (IRB) for Ethics in Clinical Study of Saitama Medical Center, Saitama Medical University
Address
1981 Kamoda, Kawagoe, Saitama, Japan
Tel
049-228-3400
asami@saitama-med.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
埼玉医科大学総合医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 26 | Day |
Last modified on
| 2019 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014850
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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