UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029187
Receipt No. R000031962
Scientific Title Open-label, non-controlled study of new intramedullary guide for total knee arthroplasty (TKA), linked with 3D surgical support software.
Date of disclosure of the study information 2017/09/19
Last modified on 2018/11/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Open-label, non-controlled study of new intramedullary guide for total knee arthroplasty (TKA), linked with 3D surgical support software.
Acronym Study of new intramedullary guide for TKA, linked with 3D surgical support software.
Scientific Title Open-label, non-controlled study of new intramedullary guide for total knee arthroplasty (TKA), linked with 3D surgical support software.
Scientific Title:Acronym Study of new intramedullary guide for TKA, linked with 3D surgical support software.
Region
Japan

Condition
Condition Patients with knee joint disease who are scheduled to undergo total knee arthroplasty (osteoarthritis, rheumatoid arthritis, knee osteonecrosis).
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of total knee arthroplasty using new intramedullary guide, linked with 3D surgical support software in patients with knee joint disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference between 3D pre-operative planning and post-operative implantation (by tibial component, internal and external rotation).
Key secondary outcomes Difference between 3D pre-operative planning and post-operative implantation (by other than tibial component, internal and external rotation).
Adverse event.

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
Device,equipment
Interventions/Control_1 Using new intramedullary guide linked with 3D surgical support software for total knee arthroplasty
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Patients with knee joint disease (osteoarthritis, rheumatoid arthritis, knee osteonecrosis).
(2)Patients who are scheduled to undergo total knee arthroplasty.
(3)Age more than 20 years, at the time of acquiring consent.
(4)Document consent can be obtained by the patient's free will, after receiving sufficient explanation for the participation of this study, after understanding.
Key exclusion criteria (1)Patients judged by the principal investigator to be inappropriate as subjects.
(2)Patients who have been registered in this study in the past.
(3)Patients with or suspected to have Creutzfeldt-Jakob disease.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daihei Kida
Organization National Hospital Organization Nagoya Medical Center
Division name Orthopedic Surgery and Rheumatology
Zip code
Address 4-1-1 Sannomaru, Naka-ku, Nagoya-shi, Aichi, 460-0001, Japan
TEL 052-951-1111
Email kidad@nnh.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daihei Kida
Organization National Hospital Organization Nagoya Medical Center
Division name Orthopedic Surgery and Rheumatology
Zip code
Address 4-1-1 Sannomaru, Naka-ku, Nagoya-shi, Aichi, 460-0001, Japan
TEL 052-951-1111
Homepage URL
Email kidad@nnh.hosp.go.jp

Sponsor
Institute National Hospital Organization Nagoya Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization Nagoya Medical Center
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
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 独立行政法人 国立病院機構 名古屋医療センター

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 19 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
2017 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 19 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 09 Month 19 Day
Last modified on
2018 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031962

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.