UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040541 |
|---|---|
| Receipt number | R000046277 |
| Scientific Title | CS (Cruciate Substituting)-TKA suitable for valgus knee OA patients. |
| Date of disclosure of the study information | 2020/05/27 |
| Last modified on | 2020/05/27 14:19:48 |
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Basic information
Public title
CS (Cruciate Substituting)-TKA suitable for valgus knee OA patients.
Acronym
CS (Cruciate Substituting)-TKA suitable for valgus knee OA patients.
Scientific Title
CS (Cruciate Substituting)-TKA suitable for valgus knee OA patients.
Scientific Title:Acronym
CS (Cruciate Substituting)-TKA suitable for valgus knee OA patients.
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Is CS (Cruciate Substituting)-TKA suitable for valgus knee OA patients?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Range of motion, JOA score, WOMAC score, adverse events
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
CS TKA for Valgus Knee
Interventions/Control_2
control CS TKA for Varus knee
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
| 40 | years-old | < |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Knee OA patients
Key exclusion criteria
history of surgeries for the knee
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Iwakiri |
Organization
Shiraniwa Hospital
Division name
Department of Orthopaedic Surgery
Zip code
6300136
Address
6-10-1 Shiraniwadai Ikoma-city Nara
TEL
0743-70-0022
kenpiecekenpiece@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Iwakiri |
Organization
Shiraniwa Hospital
Division name
Department of Orthopaedic Surgery
Zip code
6300136
Address
6-10-1 Shiraniwadai Ikoma-city Nara
TEL
0743-70-0022
Homepage URL
kenpiecekenpiece@yahoo.co.jp
Sponsor or person
Institute
Shiraniwa Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Shiraniwa Hospital
Address
6-10-1 Shiraniwadai Ikoma-city Nara
Tel
0743-70-0022
kenpiecekenpiece@yahoo.co.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
| 2020 | Year | 05 | Month | 27 | 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
166
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 27 | Day |
Last modified on
| 2020 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046277
