UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective study for best APaxis of tibial side component in total knee arthroplasty
Title of the study (Brief title)	Retrospective study for best APaxis in TKA
Region	Japan

Condition
Condition	Osteoarthritis and rheumatoid arthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Determination of ideal antero-posterior axis for total knee arthroplasty
Basic objectives2	Others
Basic objectives -Others	Improvement of ROM after total knee arthroplasty
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	ROM after total knee arthroplasty
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	after total knee arthroplasty
Key exclusion criteria	There are no data more than 6 months after operation
Target sample size	40

Research contact person
Name of lead principal investigator	Tatsuo Kobayashi
Organization	National Defense Medical College
Division name	Rehabilitation
Address	3-2, Namiki, Tokorozawa
TEL	04-2995-1511
Email	tkobayas@ndmc.ac.jp

Public contact
Name of contact person	Tatsuo Kobayashi
Organization	National Defense Medical College
Division name	Rehabilitation
Address	3-2, Namiki, Tokorozawa
TEL	04-2995-1511
Homepage URL
Email	tkobayas@ndmc.ac.jp

Sponsor
Institute	National Defense Medical College hospital, Department of Rehabilitation
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)

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 10 Month 21 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 05 Month 28 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We investigate whether rotational position between femoral component and tibial component influences the ROM after total knee arthroplasty. Subjects are patients who were performed total knee arthroplasty at National Defense Medical College Hospital more than 6 months before and CT is available and we can get informed consent for research. We will get data of knee joint ROM more than 6 months after total knee arthroplasty and rotatinal relation between femoral and tibial component using CT.

Management information
Registered date	2015 Year 10 Month 21 Day
Last modified on	2016 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021517