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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018207
Receipt No. R000021035
Scientific Title The effects of anatomic alignment on the clinical outcome of total knee arthroplasty: A randomized prospective study.
Date of disclosure of the study information 2015/07/10
Last modified on 2017/07/07

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Basic information
Public title The effects of anatomic alignment on the clinical outcome of total knee arthroplasty: A randomized prospective study.
Acronym Anatomically-aligned total knee arthroplasty
Scientific Title The effects of anatomic alignment on the clinical outcome of total knee arthroplasty: A randomized prospective study.
Scientific Title:Acronym Anatomically-aligned total knee arthroplasty
Region
Japan

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

Objectives
Narrative objectives1 A traditional neutral alignment total knee technique has been considered as very successful in terms of implant survivorship, however, 20% of the patients undergoing neutrally-aligned TKA are dissatisfied with the clinical results.
Recently, anatomically aligned total knee techniques have been growing in popularity among surgeons who are not completely satisfied with the outcomes of the traditional neutrally-alignment TKA.
This study is designed to seek insights on optimal implant alignment for higher patient satisfaction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes New Knee Society Score (w/Patient satisfaction) at 6mo and 1 year F/U
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 TKA reproducing each patient's original anatomy
Interventions/Control_2 TKA with conventional neutral alignment
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients indicated for TKA due to medial knee osteoarthritis
(Kellgren & Lowrence III<)
Key exclusion criteria Cases with primary cause besides osteoarthritis
Cases with inflammatory arthritis
Cases with lateral knee osteoarthritis
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Niki
Organization Keio University
Division name School of Medicine,Department of Orthopaedic Surgery
Zip code
Address Shinanomachi35, Shinjuku, Tokyo
TEL 03-5363-3812
Email y-niki@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Niki
Organization Keio University
Division name School of Medicine,Department of Orthopaedic Surgery
Zip code
Address Shinanomachi35, Shinjuku, Tokyo
TEL 03-5363-3812
Homepage URL
Email y-niki@keio.jp

Sponsor
Institute Keio University,School of Medicine,Department of Orthopaedic Surgery
Institute
Department

Funding Source
Organization MicroPort Orthopedics Japan K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization USA

Other related organizations
Co-sponsor Department of Orthopaedic Surgery, Hiratsuka Hospital
Department of Orthopaedic Surgery,Fussa Hospital
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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 07 Month 10 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 Enrolling by invitation
Date of protocol fixation
2014 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 03 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 06 Day
Last modified on
2017 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021035

Research Plan
Registered date File name
2017/07/07 研究計画 解剖学的アライメント.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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