UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026742 |
|---|---|
| Receipt number | R000030700 |
| Scientific Title | Usefulness of an Accelerometer-Based Portable Navigation System in Total Knee Arthroplasty |
| Date of disclosure of the study information | 2017/03/30 |
| Last modified on | 2017/03/28 18:39:39 |
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Basic information
Public title
Usefulness of an Accelerometer-Based Portable Navigation System in Total Knee Arthroplasty
Acronym
Usefulness of an Accelerometer-Based Portable Navigation System in Total Knee Arthroplasty
Scientific Title
Usefulness of an Accelerometer-Based Portable Navigation System in Total Knee Arthroplasty
Scientific Title:Acronym
Usefulness of an Accelerometer-Based Portable Navigation System in Total Knee Arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accuracy and blood conservation effect of a portable, accelerometer-based surgical navigation system (KneeAlign2) in total knee arthroplasty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Full length hip to ankle anterior-posterior weight bearing radiographs were obtained at 2 weeks after the surgery. The femoral component varus/valgus alignment was evaluated as follows; the femoral mechanical axis was determined by drawing a line from the center of the femoral head to the center of the intercondylar notch of the implant, then the angle between the femoral mechanical axis and a line connecting the most distal aspects of the medial and lateral femoral condyles was defined as the femoral component alignment in the coronal plane.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
From February 2014 to May 2015,121 patients were operated upon using the KneeAlign2 system for distal femoral resection (KA2 group.
Interventions/Control_2
From February 2014 to May 2015,121 patients underwent TKA using a conventional femoral IM alignment rod (IM 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
| 57 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Osteoarthritis of the knee
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tessyu Ikawa |
Organization
Hanwa Joint Reconstruction Center, Hanwa Daini Senboku Hospita
Division name
Department of Orthopaedic Surgery
Zip code
Address
3176 Fukai Kitamachi, Naka-ku, Sakai 599-8271, Japan
TEL
072-277-1401
tessyu@sk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Kadoya |
Organization
Hanwa Joint Reconstruction Center, Hanwa Daini Senboku Hospita
Division name
Department of Orthopaedic Surgery
Zip code
Address
3176 Fukai Kitamachi, Naka-ku, Sakai 599-8271, Japan
TEL
072-277-1401
Homepage URL
kadoya.yoshinori@kinshukai.or.jp
Sponsor or person
Institute
Hanwa Joint Reconstruction Center, Hanwa Daini Senboku Hospita
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2017 | Year | 03 | 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
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
| 2014 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 28 | Day |
Last modified on
| 2017 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030700
