UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015850 |
|---|---|
| Receipt number | R000014455 |
| Scientific Title | A multi-center prospective clinical study of patellofemoral joint complications and posterior displacement of tibia after Total Knee Arthroplasty with Triathlon CS (Cruciate-Substituting) Insert |
| Date of disclosure of the study information | 2014/12/04 |
| Last modified on | 2014/12/04 17:37:09 |
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Basic information
Public title
A multi-center prospective clinical study of patellofemoral joint complications and posterior displacement of tibia after Total Knee Arthroplasty with Triathlon CS (Cruciate-Substituting) Insert
Acronym
A multi-center prospective clinical study of patellofemoral joint complications and posterior displacement of tibia after Total Knee Arthroplasty with Triathlon CS (Cruciate-Substituting) Insert
Scientific Title
A multi-center prospective clinical study of patellofemoral joint complications and posterior displacement of tibia after Total Knee Arthroplasty with Triathlon CS (Cruciate-Substituting) Insert
Scientific Title:Acronym
A multi-center prospective clinical study of patellofemoral joint complications and posterior displacement of tibia after Total Knee Arthroplasty with Triathlon CS (Cruciate-Substituting) Insert
Region
| Japan |
Condition
Condition
knee osteoarthlitis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We inspect the effectiveness of the CS model insert in total knee arthroplasty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Functional outcome(KSS score,KOOS), Patient satisfaction(EQ-5D), Radiographic evaluation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient that first TKA is performed.
Age 20 years or older and 80 years younger.
Patients of knee osteoarthlitis or rheumatoid arthritis.
Informed consent.
Possible to follow up after surgery.
Key exclusion criteria
Pregnancy.
BMI 40 over.
History of previous knee surgery.
History og neurological disease.
History of Paget disease.
History of stroid therapy and immunosuppression therapy.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukiharu Hasegawa |
Organization
Nagoya university graduate school of medicine
Division name
Department of Hip and Knee reconstructive surgery
Zip code
Address
Tsurumai-cho 65, Showa-ku, Nagoya-city, Aichi-prefecture, Japan
TEL
+81-52-741-1908
hassey@med-nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi HAMADA |
Organization
Nagoya university graduate school of medicine
Division name
Department of Hip and Knee reconstructive surgery
Zip code
Address
Tsurumai-cho 65, Showa-ku, Nagoya-city, Aichi-prefecture, Japan
TEL
+81-52-741-1908
Homepage URL
thamada@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Hip and Knee reconstructive surgery, Nagoya university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Stryker Japan KK, Yoshida orthopadeic hospital, Nagoya orthopadics joint replacement clinic
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 12 | Month | 04 | 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
| 2014 | Year | 12 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
preinitiation
Management information
Registered date
| 2014 | Year | 12 | Month | 04 | Day |
Last modified on
| 2014 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014455
