UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of clinical outcome of total knee arthroplasty associated with CT-free navigation and MRI-based instruments
Title of the study (Brief title)	Comparison of clinical outcome of total knee arthroplasty associated with CT-free navigation and MRI-based instruments
Region	Japan

Condition
Condition	osteoarthritis of the knee
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare accuracy of CT-free navigation and MRI-based instruments for total knee arthroplasty.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Knee Society Score
Key secondary outcomes	Knee joint range of motion,Villalta scale, Short Form-8,Visual analog Scale(VAS),Knee Injury and Osteoarthritis Outcome Score,and alignment of femoral component and tibial component.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	MRI-based instrument
Interventions/Control_2	CT-free navigation
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	Patients who undergo primary total knee arthroplasty for osteoarthritis of the knee. Written informed consents are obtained from all the patients.
Key exclusion criteria	Patients who have complications such as interfere with general anesthesia or those that affect knee surgery. Patients with non-self-walking.
Target sample size	60

Research contact person
Name of lead principal investigator	Takayuki Furumatsu
Organization	Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Division name	Department of Orthopaedic Surgery
Address	2-5-1 Shikata-cho, Kita-ku,Okayama
TEL	086-235-7273
Email	matino@md.okayama-u.ac.jp

Public contact
Name of contact person	Takayuki Furumatsu
Organization	Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Division name	Department of Orthopaedic Surgery
Address	2-5-1 Shikata-cho, Kita-ku,Okayama
TEL	086-235-7273
Homepage URL
Email	matino@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
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

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 11 Month 01 Day
Anticipated trial start date	2014 Year 11 Month 01 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	2014 Year 10 Month 07 Day
Last modified on	2016 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017832