UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021436 |
|---|---|
| Receipt number | R000024727 |
| Scientific Title | The efficacy of KneeAlign2 navigation system for Vanguard total knee arthroplasty -randomized controlled trial- |
| Date of disclosure of the study information | 2016/03/11 |
| Last modified on | 2019/03/19 10:53:45 |
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Basic information
Public title
The efficacy of KneeAlign2 navigation system for Vanguard total knee arthroplasty -randomized controlled trial-
Acronym
The efficacy of KneeAlign2 navigation system for TKA
Scientific Title
The efficacy of KneeAlign2 navigation system for Vanguard total knee arthroplasty -randomized controlled trial-
Scientific Title:Acronym
The efficacy of KneeAlign2 navigation system for TKA
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the knee alignment between the groups with and without navigation system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative implant alignment (6 months postoperatively)
Key secondary outcomes
Knee Society score, Oxford knee score, EQ5D (6 months postoperatively)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Totoal knee arthroplasty using KneeAligne2
Interventions/Control_2
Totoal knee arthroplasty using conventional instrument
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Varus knee osteoarthritis more than grade 3 of Kellgren-Lawrence classification
Key exclusion criteria
Other than osteoarthritis
Infection
Valgus knee
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yukihide |
| Middle name | |
| Last name | Yukihide Minoda |
Organization
Osaka City University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
545-8585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3851
yminoda@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yukihide |
| Middle name | |
| Last name | Minoda |
Organization
Osaka City University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
5458585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3851
Homepage URL
yminoda@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
ZimmerBiomet
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University Graduate School of Medicine
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
Tel
0666453851
yminoda@msic.med.osaka-cu.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 11 | Day |
Related information
URL releasing protocol
https://clinicaltrials.gov/ct2/show/NCT02695329
Publication of results
Unpublished
Result
URL related to results and publications
Non
Number of participants that the trial has enrolled
100
Results
Six patients in the navigation group and 15 patients in the conventional group had an alignment which was > 2 degrees away from the neutral mechanical axis of tibia (p <0.05). The mean deviation from neutral alignment of tibia was 1.2 +/- 1.2 degrees (mean +/- SD) in the navigation group and 1.7 +/- 1.1 degrees in the conventional group (p <0.05). The mean deviation from neutral alignment of femur was 1.4 +/- 1.3 degrees in the navigation group and 1.9 +/- 1.4 degrees in the conventional group (p <0.05).
Results date posted
| 2019 | Year | 03 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 100 patients with primary varus osteoarthritis of the knee
Participant flow
The navigation system was used in 50 patients (navigation group) and a conventional intramedullary femoral guide and extramedullary tibial guide were used in 50 patients (conventional group).
Adverse events
Non
Outcome measures
Alignment Clinical Scores
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 11 | Day |
Last modified on
| 2019 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024727
