UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000021436
Receipt No. 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 (Ver. 12)

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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
Last 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
Email yminoda@msic.med.osaka-cu.ac.jp

Public contact
1st 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
Email yminoda@msic.med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024727