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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004102
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Zimmer K.K.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003594

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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