UMIN-CTR Clinical Trial

Basic information
Public title	Clinical studies of the osteotomy for osteoarthritis of knee
Acronym	Clinical outcome study of the tibial condyle valgus osteotomy
Scientific Title	Retrospective observational study
Scientific Title:Acronym	Observational study
Region	Japan

Condition
Condition	gonarthrosis
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We analyze the tibial condyle valgus osteotomy from a multidirectional viewpoint, and clarify the mechanisms, effects, indications, and complications of the surgery method.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Image study findings (CT, MRI, simple X-rays) and rehabilitation information (Muscular strength, range of motion, walk, ADL) at 6 months, 1 year, and 2 years after surgery.
Key secondary outcomes	JOA score, KOOS score, VAS, %MA, movement analysis

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 considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	High tibial osteotomy
Interventions/Control_2	Tibial condyle valgus osteotomy
Interventions/Control_3	High tibial osteotomy+Tibial condyle valgus osteotomy
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	The patients who were indicated osteotomy surgery
Key exclusion criteria	The case that can not follow up
Target sample size	41

Research contact person
Name of lead principal investigator	1st name HIRONOBU Middle name Last name KOSEKI
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Locomotive Rehabilitation Science
Zip code	852-8520
Address	1-7-1, Sakamoto, Nagasaki 852-8501, Japan
TEL	+81958197321
Email	koseki@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Hironobu Middle name Last name Koseki
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Locomotive Rehabilitation Science, Unit of Rehabilitation sciences
Zip code	852-8520
Address	1-7-1, Sakamoto, Nagasaki 852-8501, Japan
TEL	+81-95-819-7321
Homepage URL	http://www.mdp.nagasaki-u.ac.jp/
Email	koseki@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization	KAKENHI 15K01372
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The research ethics committee at Nagasaki University
Address	1-7-1, Sakamoto
Tel	+81958197321
Email	koseki@nagasaki-u.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	2015 Year 09 Month 06 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	64
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	2015 Year 09 Month 05 Day
Date of IRB	2015 Year 08 Month 25 Day
Anticipated trial start date	2015 Year 09 Month 06 Day
Last follow-up date	2019 Year 11 Month 11 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 09 Month 05 Day
Last modified on	2019 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021886