UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028393 |
|---|---|
| Receipt number | R000032395 |
| Scientific Title | Three-dimensional motion analysis after FINE total knee arthroplasty with low-constrained polyethylene insert |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2019/12/03 17:23:10 |
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Basic information
Public title
Three-dimensional motion analysis after FINE total knee arthroplasty with low-constrained polyethylene insert
Acronym
3D FINE flat
Scientific Title
Three-dimensional motion analysis after FINE total knee arthroplasty with low-constrained polyethylene insert
Scientific Title:Acronym
3D FINE flat
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee (post total knee arthroplasty)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate tendency of knee motion after FINE knee total knee arthroplasty when using low constrained flat surface polyethylene
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relative position of the femur calculated at each 10 degree of knee flexion angle using the tibia as reference line when conducting walking, squatting, climbing stairs, and descend stairs.
Key secondary outcomes
Knee injury and Osteoarthritis Outcome Score
Forgotten Joint Score-12
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
X-ray
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who received total knee arthroplasty with FINE Knee flat surface system
Key exclusion criteria
1) Those who did not consent with the study
2) Post-surgical infection
3) Thrombotic disease after surgery
4) Those who were not adequate for study judged by doctors in charge
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takahisa |
| Middle name | |
| Last name | Sasho |
Organization
Chiba University
Division name
Center for preventive medical sciences
Zip code
2608670
Address
1-8-1, Inohana, Chiba, Cyuou
TEL
043-226-2017
sasho@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Takahisa |
| Middle name | |
| Last name | Sasho |
Organization
Chiba University
Division name
Center for preventive medical sciences
Zip code
2608670
Address
1-8-1, Inohana, Chiba, Cyuou
TEL
043-226-2017
Homepage URL
sasho@faculty.chiba-u.jp
Sponsor or person
Institute
Center for preventive medical sciences
Institute
Department
Personal name
Funding Source
Organization
Center for preventive medical sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Orthopedic Surgery, Osaka University
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Chiba University Hospital Clinical Research Center
Address
1-8-1, Inohana, Chiba, Cyuou
Tel
043-222-7171
ayamazaki@office.chiba-u.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
| 2017 | Year | 10 | Month | 01 | 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
12
Results
In vivo kinematics after total knee arthroplasty (TKA) with mild constrained polyethlene was identical to that with conventinal constrained polyethelene.
Results date posted
| 2019 | Year | 12 | Month | 03 | Day |
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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 03 | 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 | 07 | Month | 27 | Day |
Last modified on
| 2019 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032395
