UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007291 |
|---|---|
| Receipt number | R000008582 |
| Scientific Title | Comparison conventional and new tibial inserts in Bi-Surface type total knee arthroplasty |
| Date of disclosure of the study information | 2012/02/20 |
| Last modified on | 2014/08/14 14:25:13 |
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Basic information
Public title
Comparison conventional and new tibial inserts in Bi-Surface type total knee arthroplasty
Acronym
Comparison conventional and new tibial inserts in Bi-Surface type total knee arthroplasty
Scientific Title
Comparison conventional and new tibial inserts in Bi-Surface type total knee arthroplasty
Scientific Title:Acronym
Comparison conventional and new tibial inserts in Bi-Surface type total knee arthroplasty
Region
| Japan |
Condition
Condition
osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Bi-surface type prosthesis have been used in total knee arthroplasty at our institution. Tibial internal rotation during deep flexion was observed in Bi-surface type prosthesis at fluoroscopic analyses. In conventional inserts (dish-type), medial liftoff occurs because posterior subluxation of the lateral femoral condyle dose not occur. Other reports have revealed that eccentric loading of the tibial insert occurs in the liftoff position. Therefore, new inserts modify to medial dish and lateral flat form. But, clinical results of the new inerts have not been showed. This study aims to clarity differences between the conventional and new tibial inserts in the knee stability, the soft tissue balance, the range of motion, and clinical evaluation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
lateral instability more than 10 degree, Aseptic loosening, Revision
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
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Bi-surface knee conventional tibial insert (KU4+)
Interventions/Control_2
Bi-surface knee new tibial insert (BS5)
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
| 35 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Osteoarthritis higher than grade 2 (Koshino grade), and higher than 35 years old. Primary total knee arthroplasty.
Key exclusion criteria
can not use intramedulary rods.
can not use balancer.
malignancy diseases, cerebral infarction, parkinson disease, paralysis, tremor diseases, spastic diseases,
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Moritoshi Furu |
Organization
Graduate school of medicine, Kyoto University
Division name
department of the Control for Rheumatic diseases
Zip code
Address
54 Kawahara-cho Shogoin Sakyo-ku Kyoto
TEL
075-751-3877
morifuru-@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Moritoshi Furu |
Organization
Graduate school of medicine, Kyoto University
Division name
department of the Control for Rheumatic diseases
Zip code
Address
54 Kawahara-cho Shogoin Sakyo-ku Kyoto
TEL
0757513877
Homepage URL
morifuru@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate school of medicine, kyoto University
Institute
Department
Personal name
Funding Source
Organization
none
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 14 | Day |
Last modified on
| 2014 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008582
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
