UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of component position after total knee arthroplasty using navigation system: a prospective study
Title of the study (Brief title)	Component position after navigated total knee arthroplasty
Region	Japan

Condition
Condition	Knee osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare accuracy of component position and clinical score in navigated total knee arthroplasty between balanced and measured-resection techniques
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Radiograph, CT and clinical evaluation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Balanced methods
Interventions/Control_2	Mesured resection method
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	40 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with knee osteoarthritis and treatment of total knee arthroplasty
Key exclusion criteria	Deformity due to previous operation or injury
Target sample size	100

Research contact person
Name of lead principal investigator	Yasushi Akamatsu
Organization	Yokohama City University School of Medicine
Division name	Orthopaedic Surgery
Address	3-9, Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2655
Email	akamatsu@yokohama-cu.ac.jp

Public contact
Name of contact person	Yasushi Akamatsu
Organization	Yokohama City University School of Medicine
Division name	Orthopaedic Surgery
Address	3-9, Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2655
Homepage URL
Email	akamatsu@yokohama-cu.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	Yokohama City University Hospital

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 17 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 01 Month 09 Day
Anticipated trial start date	2015 Year 02 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 16 Day
Last modified on	2017 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021631