UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004102 |
|---|---|
| Receipt number | R000003594 |
| Scientific Title | Clinical Study of TM-Tibia/Patella |
| Date of disclosure of the study information | 2010/08/25 |
| Last modified on | 2010/08/25 19:48:09 |
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Basic information
Public title
Clinical Study of TM-Tibia/Patella
Acronym
Clinical Study of TM-Tibia/Patella
Scientific Title
Clinical Study of TM-Tibia/Patella
Scientific Title:Acronym
Clinical Study of TM-Tibia/Patella
Region
| Japan |
Condition
Condition
Patients with knee pain and dysfunction who have been diagnosed to require knee replacement
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of TM-Tibia/Patella in TKA and to determine its usefulness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
(1)Efficacy evaluation
Efficacy evaluation was performed using the following four categories of evaluation criteria based on the improvement rate by the JOA score and X-ray evaluation at 12 months postoperatively; Markedly effective, Effective, Slightly effective and Ineffective
(2) Safety evaluation
The clinical safety was evaluated based on the following four categories by comprehensively considering the adverse events; Safe, Almost safe, Insufficiently safe and Not safe
(3) Usefulness evaluation
The usefulness was judged according to the following five categories based on the matrix of efficacy and safety evaluation; Very useful, Useful,Slightly useful, Not useful and Contraindicated
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Implantation of TM-Tibia/Patella by TKA
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)A patient with knee pain and dysfunction who has been diagnosed to require total knee replacement and to be indicated for a cementless fixation at the tibial side.
(2)A patient who understands the purpose of this clinical study and has provided a written consent.
(3)A patient who may be followed up for 12 months postoperatively.
Key exclusion criteria
(1)A patient with a previous history of infection in the affected joint.
(2)A patient with insufficient bone stock on tibial, femoral or patellar surfaces.
(3)A patient with a skeletal immaturity.
(4)A patient with neuropathic arthropathy.
(5)A patient with infection-like symptoms.
(6)A patient with rheumatoid arthritis with a previous history of skin ulcer or recurrent skin breakdown.
(7)A patient with osteoporosis or a neuromuscular disease that may compromise the affected limbs.
(8)A patient with severe instability secondary to absence of a collateral ligament.
(9)A patient who has been judged ineligible for the conduct of the study by the study investigator.
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Nakagawa, MD |
Organization
Former Fujita Health University
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho Toyoake-shi, Aichi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikio Ishikawa |
Organization
Zimmer K.K.
Division name
Clinical Affairs
Zip code
Address
4-1-17 Toranomon, Minato-ku, Tokyo
TEL
03-6402-6671
Homepage URL
Sponsor or person
Institute
Zimmer K.K.
Institute
Department
Personal name
Funding Source
Organization
Zimmer K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
藤田保健衛生大学病院
大阪市立大学医学部附属病院
筑波大学附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 25 | 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
Completed
Date of protocol fixation
| 2004 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 25 | Day |
Last modified on
| 2010 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003594
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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