UMIN-CTR Clinical Trial

Basic information
Public title	Ideal antero-posterior axis for tibial component in total knee arthroplasty
Acronym	Ideal antero-posterior axis in total knee arthroplasty
Scientific Title	Ideal antero-posterior axis for tibial component in total knee arthroplasty
Scientific Title:Acronym	Ideal antero-posterior axis in total knee arthroplasty
Region	Japan

Condition
Condition	Osteoarthritis of the knee, Rheumatoid arthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate whether placeing the femoral and tibial component according to the epicondyle line results in good ROM after total knee arthroplasty.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Post operative ROM of the knee
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients for tatal knee arthroplasty in National Defense Medical College Hospital
Key exclusion criteria	No CT or MRI before and after total knee arthroplasty
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Tatsuo Middle name Last name Kobayashi
Organization	National Defense Medical College
Division name	Rehabilitation
Zip code	359-8513
Address	3-2, Namiki, Tokorozawa
TEL	04-2995-1511
Email	tkobayas@ndmc.ac.jp

Public contact
1st name of contact person	1st name Tatsuo Middle name Last name Kobayashi
Organization	National Defense Medical College
Division name	Rehabilitation
Zip code	359-8513
Address	3-2, Namiki, Tokorozawa
TEL	04-2995-1511
Homepage URL
Email	tkobayas@ndmc.ac.jp

Sponsor
Institute	National Defense Medical College
Institute
Department

Funding Source
Organization	National Defense Medical College
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Defense Medical College
Address	3-2, Namiki, Tokorozawa, Saitama
Tel	04-2995-1511
Email	ins010@ndmc.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	防衛医科大学校

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 21 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	Terminated
Date of protocol fixation	2015 Year 07 Month 08 Day
Date of IRB	2019 Year 04 Month 24 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2019 Year 04 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We investigate whether pre-operative determination of tibial component position using MRI or CT according to the epicondyle axis results in good ROM after total knee arthroplasty. Subjects are patients performed total knee arthroplasty in accordance with pre-operatively determined antero-posterior axis using MRI or CT from 2016 April 1 to 2018 May 31. We are planning collect 40 subjects. We evaluate knee joint ROMs 6 months after operation and compare them with the ROMs of knee joints operated before 2016 May 31.

Management information
Registered date	2015 Year 10 Month 21 Day
Last modified on	2019 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022491