UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032700 |
|---|---|
| Receipt number | R000037291 |
| Scientific Title | Efficasy of a cementless total knee arthroplasty. |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2022/11/25 16:17:03 |
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Basic information
Public title
Efficasy of a cementless total knee arthroplasty.
Acronym
Efficasy of a cementless total knee arthroplasty.
Scientific Title
Efficasy of a cementless total knee arthroplasty.
Scientific Title:Acronym
Efficasy of a cementless total knee arthroplasty.
Region
| Japan |
Condition
Condition
Osteoarthrotis, Osteonecrosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficasy of a cementless total knee arthroplasty, this study will compare clinical outcomes of cement and cementless total knee arthroplasty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical evaluation and plane radiographic findings at 1 year after total knee arthroplasty.
Key secondary outcomes
Clinical evaluation and plane radiographic findings at 3 and 6 months after total knee arthroplasty.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Surgical procedure of cementless total knee arthroplasty.
Cementless group 20 cases.
Interventions/Control_2
Surgical procedure of cement total knee arthroplasty.
Cement group 20 cases.
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
Cases who adapted to total knee arthroplasty and obtained consent by document.
Key exclusion criteria
Cases which reserchers judge inappropriate(example revision surgery)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Minami |
Organization
Sumiya orthopaedics hospital
Division name
Department of orthopaedics surgery
Zip code
640-8343
Address
337 Yoshida, Wakayama
TEL
073-433-1161
crddp728@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Minami |
Organization
Sumiya orthopaedics hospital
Division name
Department of orthopaedics surgery
Zip code
640-8343
Address
337 Yoshida, Wakayama
TEL
073-433-1161
Homepage URL
crddp728@yahoo.co.jp
Sponsor or person
Institute
Sumiya orthopaedics hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sumiya orthopaedics hospital
Address
337 Yoshida, Wakayama
Tel
073-433-1161
sanada@sumiya.or.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
| 2018 | Year | 06 | 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
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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 24 | Day |
Last modified on
| 2022 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037291
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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