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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012711
Receipt No. 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

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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
Email 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
Email hiraoka@saitama-med.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Saitama Medical Center, Saitama Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014850

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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