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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002706
Receipt No. 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 2014/05/05

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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
Email 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
Email hiromu@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine,
Department of Orthopaedic Surgery
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2009 Year 10 Month 28 Day
Date of IRB
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
2014 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003299

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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