UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002706 |
|---|---|
| Receipt number | R000003299 |
| Scientific Title | Computer-assisted preoperative design on total knee arthroplasty compared with standard X-ray design: A prospective randomized study |
| Date of disclosure of the study information | 2009/11/05 |
| Last modified on | 2023/07/17 13:23:49 |
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Basic information
Public title
Computer-assisted preoperative design on total knee arthroplasty compared with standard X-ray design: A prospective randomized study
Acronym
Computer-assited preoperative design
Scientific Title
Computer-assisted preoperative design on total knee arthroplasty compared with standard X-ray design: A prospective randomized study
Scientific Title:Acronym
Computer-assited preoperative design
Region
| Japan |
Condition
Condition
Knee arthropathy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether computer-assisted preoperative design influences favorably on total knee arthroplasty outcome compared standard X-ray design
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Femoral and tibial component position will be assessed in CT and X-ray based preoperative design groups
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Total knee arthroplasty will be performed based on standard X-ray-based preoperative design
Interventions/Control_2
Total knee arthroplasty will be performed based on computer-assisted preoperative design
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
| 25 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
knee OA patient with KL grade III or more and knee RA patients with Larsen 3 or more suitable for primary total knee arthroplasty
Key exclusion criteria
Patients who;
1, have severe diseases unsuitable for total knee arthroplasty
2, have severe deformity unsuitable for total knee arthroplasty
3, have milder deformity more suitable for joint preserving operation
4, have knee deformity suitable for more constrained implant
5, have had metal implant not suitable for CT evaluation or intramedually rod
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromu Ito |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
54 Kawahara-cho, Shogoin,Sakyo, Kyoto 606-8507, Japan
TEL
075-751-3652
hiromu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromu Ito |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
54 Kawahara-cho, Shogoin,Sakyo, Kyoto 606-8507, Japan
TEL
075-751-3652
Homepage URL
hiromu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine,
Department of Orthopaedic Surgery
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 05 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2009 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 04 | Day |
Last modified on
| 2023 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003299
