UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022555 |
|---|---|
| Receipt number | R000025994 |
| Scientific Title | The verification study on correlative relationship between bone resection volume and outcomes in the TKA with .Triathlon CR/PS and Advanced-Gap-Sezer. |
| Date of disclosure of the study information | 2016/06/06 |
| Last modified on | 2021/10/27 11:05:46 |
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Basic information
Public title
The verification study on correlative relationship between bone resection volume and outcomes in the TKA with .Triathlon CR/PS and Advanced-Gap-Sezer.
Acronym
Triathlon & AGS Study
Scientific Title
The verification study on correlative relationship between bone resection volume and outcomes in the TKA with .Triathlon CR/PS and Advanced-Gap-Sezer.
Scientific Title:Acronym
Triathlon & AGS Study
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy on outcomes of TKA using Triathlon Knee system which is single radius design by accurate bone resection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Radiographic evaluation.
Functional Score.
Patients satisfaction.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients are candidate for primary TKA.
2) Patients have diagnosis of OA.
3) Patients are age 20 or over.
4) Patient, who can walk independently without assistance person.
5) Patients, who agree on an IRB-approved, study specific Informed Patient Consent Form
6) Patients are willing and able to comply with postoperative scheduled evaluations
Key exclusion criteria
1) Patients have bacterial infectious disease or have risk highly of bacterial infection.
2) Patients requiring revision surgery.
3) Patients, who are severe Baker's leg (FTA < 165 degree).
4) Patients had bone osteotomy to tibia.
5) Patients, who are morbidly obese, defined as having a Body Mass Index (BMI) > 40.
6) Patients who is pregnant female or maybe so.
7) Patients who have a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
8) Patients with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
9) Patients who are immunologically suppressed or receiving chronic steroids.
10) Patients who are judged ineligible with reasonable reason by primary doctor.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazue Hayakawa |
Organization
Fujita Health University
Division name
Graduate School of Medicine
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN
TEL
0562-93-2635
hkazue@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Motohashi |
Organization
Stryker Japan K.K.
Division name
Clinical Affairs
Zip code
Address
2-6-1, Koraku, Bunkyo-ku, Tokyo, 112-0004 Japan
TEL
03-6894-8219
Homepage URL
satoru.motohashi@stryker.com
Sponsor or person
Institute
Stryker Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
Stryker Japan K.K.
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
| 2016 | Year | 06 | Month | 06 | 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
208
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
| 2015 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-center, Prospective, Observational research (non-intervention, minimal invasive)
Management information
Registered date
| 2016 | Year | 05 | Month | 31 | Day |
Last modified on
| 2021 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025994
| 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 |
