UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018207 |
|---|---|
| Receipt number | 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 | 2021/09/08 08:46:56 |
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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 | Yasuo |
| Middle name | |
| Last name | Niki |
Organization
Keio University
Division name
School of Medicine,Department of Orthopaedic Surgery
Zip code
1608582
Address
Shinanomachi35, Shinjuku, Tokyo
TEL
0353633812
y-niki@keio.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Niki |
Organization
Keio University
Division name
School of Medicine,Department of Orthopaedic Surgery
Zip code
1608582
Address
Shinanomachi35, Shinjuku, Tokyo
TEL
0353633812
Homepage URL
y-niki@keio.jp
Sponsor or person
Institute
Keio University,School of Medicine,Department of Orthopaedic Surgery
Institute
Department
Personal name
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
Keio University
Address
35, Shinanomachi, Shinjuku
Tel
0353633812
y-niki@keio.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
in submission to American journal
Publication of results
Unpublished
Result
URL related to results and publications
in submission to the Journal (Arthroplasty today)
Number of participants that the trial has enrolled
16
Results
anatomically aligned TKA exhibited greater internal rotation ot the tibia relative to femur during gait, suggesting that anatomical alignment restored normal knee kinematics in OA patients.
Results date posted
| 2021 | Year | 09 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
KL4 endstage OA
Participant flow
excluded patients refusing radiological exposure during gait analysis and image fluoroscopic analysis
Adverse events
none
Outcome measures
gait parameter
knee rotation angle
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 09 | Day |
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
| 2021 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021035
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/09/03 | figure 0202二木.pptx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/09/03 | Manuscript.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/09/03 | Manuscript.docx |
