UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055923 |
|---|---|
| Receipt number | R000063906 |
| Scientific Title | Reliability and Accuracy of a New Accelerometer-Based Portable Navigation System for Total Knee Arthroplasty |
| Date of disclosure of the study information | 2024/10/24 |
| Last modified on | 2025/04/24 11:08:49 |
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Basic information
Public title
Reliability and Accuracy of a New Accelerometer-Based Portable Navigation System for Total Knee Arthroplasty
Acronym
Reliability and Accuracy of a New Accelerometer-Based Portable Navigation System for Total Knee Arthroplasty
Scientific Title
Reliability and Accuracy of a New Accelerometer-Based Portable Navigation System for Total Knee Arthroplasty
Scientific Title:Acronym
Reliability and Accuracy of a New Accelerometer-Based Portable Navigation System for 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
Investigation of the reliability and accuracy of measurements of the coronal and sagittal plane alignment of components and soft tissue balance in total knee arthroplasty using a new accelerometer-based portable navigation system (Lantern, OrthoAlign)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of TKA component placement using the Lantern system. The absolute value of the error between the angles and distances displayed on the Lantern system intraoperatively and those measured using the pre- and post-operative CT scans.
Key secondary outcomes
Reliability of TKA component placement using the Lantern system
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing primary TKA using the Lantern system for medial osteoarthritis of the knee
Key exclusion criteria
Patients with other than medial osteoarthritis of the knee (lateral osteoarthritis of the knee, rheumatoid arthritis, osteonecrosis, fracture, pyogenic arthritis of the knee). Patients who
undergoing revision total knee arthroplasty.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Ohyama |
Organization
Koryokai Hospital
Division name
Orthopaedic surgery
Zip code
547-0044
Address
4-15-6 Hirano-Honmachi, Hirano-ku, Osaka City
TEL
+81-6-6791-0928
kaiba_uc_now@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Ohyama |
Organization
Koryokai Hospital
Division name
Orthopaedic surgery
Zip code
547-0044
Address
4-15-6 Hirano-Honmachi, Hirano-ku, Osaka City
TEL
+81-6-6791-0928
Homepage URL
kaiba_uc_now@yahoo.co.jp
Sponsor or person
Institute
Koryokai Hospital
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
IRB at Koryokai Hospital
Address
4-15-6 Hirano-Honmachi, Hirano-ku, Osaka City
Tel
06-6791-0928
swakitani44@gmail.com
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
高遼会病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This cohort study will prospectively collect patients undergoing their first TKA using the Lantern for medial knee osteoarthritis at our hospital from October 30, 2024. Cases other than medial osteoarthritis of the knee (lateral osteoarthritis of the knee, rheumatoid arthritis, osteonecrosis, fracture, pyogenic arthritis of the knee), and revision cases will be excluded. The number of cases is planned to be 30. Regular imaging tests (CT scans before and seven days after surgery) will be performed during the preoperative and postoperative hospital stays. These will not involve any major changes to the usual clinical care. There are no plans for any particularly invasive additional tests. During surgery, the angles (coronary and sagittal plane alignment of the femur and tibia, rotation of the femur) and distances (extension gap, flexion gap) displayed on the Lantern will be recorded. Patient characteristics data will include age, gender, height, weight, body mass index, and the side of the knee (left or right) being operated on.
The primary outcome is the accuracy of TKA placement using the Lantern. We will evaluate the absolute value error and the proportion of outliers (angles greater than 2 or 3 degrees, distances greater than 1 mm or 2 mm) between the angles and distances displayed on the Lantern during surgery (amount of osteotomy of the posterior femoral condyle) and the true values measured using preoperative and postoperative CT. A secondary outcome is the reliability of intraoperative Lantern measurements. The intra- and inter-observer mean errors and reliability of the displayed angles and distances will be assessed using intraclass correlation coefficients, with measurements taken by two independent observers, one of whom will take two measurements. Each data set will be taken prospectively, but no particularly invasive examinations or special treatments will be performed.
Management information
Registered date
| 2024 | Year | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063906
