UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026895 |
|---|---|
| Receipt number | R000030854 |
| Scientific Title | Randomized controlled study comparing kinematically aligned technique with mechanically aligned technique in total knee arthroplasty |
| Date of disclosure of the study information | 2017/04/14 |
| Last modified on | 2022/10/11 17:36:32 |
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Basic information
Public title
Randomized controlled study comparing kinematically aligned technique with mechanically aligned technique in total knee arthroplasty
Acronym
Randomized controlled study comparing kinematically aligned technique with mechanically aligned technique in total knee arthroplasty
Scientific Title
Randomized controlled study comparing kinematically aligned technique with mechanically aligned technique in total knee arthroplasty
Scientific Title:Acronym
Randomized controlled study comparing kinematically aligned technique with mechanically aligned technique in total knee arthroplasty
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, a patient with knee osteoarthritis resistant to conservative therapy has undergone Kinematically aligned total knee arthroplaty. In the present study, the kinematically aligned total knee arthroplasty was compared with mechanically aligned total knee arthroplasty that has been commonly performed in many hospitals.
Basic objectives2
Others
Basic objectives -Others
to evaluate the surgical technique in total knee arthroplaty
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative patient-derived outcome
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
kinematically aligened total knee arthroplaty
Interventions/Control_2
mechanically aligned total knee arthroplasty
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. osteoarthritis
2. kellgren-Lawrence grade4
3. patients who agreed the present study
Key exclusion criteria
1. Rheumatoid arthritis
2. revision total knee arthroplasty
3. impossible to gait
4. infection
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Matsumoto |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5111
matsun@m4.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Kuroda |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5111
Homepage URL
0321yuichi0321@gmail.com
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine
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
Address
Tel
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
| 2017 | Year | 04 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 07 | Day |
Last modified on
| 2022 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030854
