UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017889 |
|---|---|
| Receipt number | R000020722 |
| Scientific Title | Rotational position of tibial component in total knee arthroplasty - a prospective study - |
| Date of disclosure of the study information | 2015/06/12 |
| Last modified on | 2023/12/19 18:21:40 |
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Basic information
Public title
Rotational position of tibial component in total knee arthroplasty - a prospective study -
Acronym
Rotational position of tibial component in total knee arthroplasty - a prospective study -
Scientific Title
Rotational position of tibial component in total knee arthroplasty - a prospective study -
Scientific Title:Acronym
Rotational position of tibial component in total knee arthroplasty - a prospective study -
Region
| Japan |
Condition
Condition
Osteoarthritis, rheumatoid arthritis, osteonecrosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the rotational position of tibial component in TKA using the CT-based navigation system and the manual method and to evaluate the intra-observer and inter-observer reliabilities
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To measure the rotational position of tibial component in TKA using the CT-based navigation system and the manual method and to evaluate the intra-observer and inter-observer reliabilities
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After registration of the rotational position of tibial component using the CT-based navigation system, the position was compared with the position which was registered by the manual method. The manual registration is performed by two surgeons in duplicate before and after proximal tibial cut.
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
| 30 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with osteoarthritis, osteonecrosis, and rheumatoid arthritis undergoing total knee arthroplaties.
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Kobayashi |
Organization
Yokohama City University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
2360004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
045-787-2655
hi-deo@live.jp
Public contact
Name of contact person
| 1st name | Hideo |
| Middle name | |
| Last name | Kobayashi |
Organization
Yokohama City University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
2360004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
045-787-2800
Homepage URL
hi-deo@live.jp
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University School of Medicine
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
Tel
045-787-2800
hi-deo@live.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
| 2015 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
https://jsjd.info/magazine/
Publication of results
Unpublished
Result
URL related to results and publications
https://jsjd.info/magazine/
Number of participants that the trial has enrolled
22
Results
The angles between CT-Akagis line and M-Akagis line were observer A 2.5 / B -0.1 preoperatively, and those were observer A 1.1 / B -3.1 postoperatively. The rates of outliers were observer A 23% / B 18% preoperatively, and those were observer A 18% / B 23% postoperatively.
Results date posted
| 2023 | Year | 12 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
22 patients with knee osteoarthritis were enrolled in this prospective study.
Participant flow
22 patients with knee osteoarthritis were enrolled in this prospective study.
Adverse events
none.
Outcome measures
Preoperative computed tomography scans were performed to identify the Akagis line. The line was incorporated in the CT based navigation system and defined as CT-Akagis line. Two observers (observer A / B) determined the Akagis line (M-Akagis line) manually without referring navigation before and after proximal tibial cut. The angle between CT-Akagis line and M-Akagis line and the outlier of the angle were investigated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020722
