UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027545 |
|---|---|
| Receipt number | R000031583 |
| Scientific Title | Randomized controlled study comparing iASSIST Knee system versus conventional instrumentation |
| Date of disclosure of the study information | 2017/05/30 |
| Last modified on | 2019/12/11 13:08:28 |
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Basic information
Public title
Randomized controlled study comparing iASSIST Knee system versus conventional instrumentation
Acronym
iASSIST Comparison Study
Scientific Title
Randomized controlled study comparing iASSIST Knee system versus conventional instrumentation
Scientific Title:Acronym
iASSIST Comparison Study
Region
| Japan |
Condition
Condition
Knee Joint Diseases
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The alignment accuracy of the knee femoral and tibial components at 6 months for the investigational group compared to the control group.
Key secondary outcomes
Health Status after TKA, Operating Room efficiency and Complication rate after TKA for the investigational group compared to the control group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Persona TKA with iASSIST Knee as the Investigational group
Interventions/Control_2
Persona TKA with conventional instrumentation and without iASSIST Knee as the Control group
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
- Knee Osteoarthritis (varus deformity only)
- Subjects willing to return for follow-up evaluations
Key exclusion criteria
- Severe OA deformation (FTA:>190 deg/ <175 deg)
- Active Infection (or within 6 weeks after infection)
- Sepsis
- Osteomyelitis
- Any type of implant is inserted in the affected side of lower extremity
- Hip and lower limb diseases on the affected side
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- diagnosed Osteoporosis or Osteomalacia
- Metabolic disorders which may impair bone formation
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy or neuromuscular disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fumiya |
| Middle name | |
| Last name | Ohmasa |
Organization
Zimmer Biomet G. K.
Division name
Clinical Affairs
Zip code
105
Address
11-1, Shibakoen 2-chome, Minato-ku, Tokyo, Japan
TEL
08019946090
fumiya.ohmasa@zimmerbiomet.com
Public contact
Name of contact person
| 1st name | Fumiya |
| Middle name | |
| Last name | Ohmasa |
Organization
Zimmer Biomet G. K.
Division name
Clinical Affairs
Zip code
105-0011
Address
11-1, Shibakoen 2-chome, Minato-ku, Tokyo, Japan
TEL
03-6402-6762
Homepage URL
fumiya.ohmasa@zimmerbiomet.com
Sponsor or person
Institute
Zimmer Biomet G. K.
Institute
Department
Personal name
Funding Source
Organization
Zimmer Biomet G. K.
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
Institutional Review Board of Nippon Medical School Foundation
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel
03-5802-8202
officetokutei@nms.ac.jp
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
福岡整形外科病院(福岡県)、住友病院(大阪府)、日本大学医学部附属板橋病院(東京都)、山口県立総合医療センター(山口県)、日本赤十字社医療センター(東京都)、熊本大学医学部附属病院(熊本県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 30 | 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
93
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
| 2016 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 30 | Day |
Last modified on
| 2019 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031583
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