UMIN-CTR Clinical Trial

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