UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029187
Receipt number 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 16:31:29

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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 or person

Institute

National Hospital Organization Nagoya Medical Center

Institute

Department

Personal name



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

Value
https://center6.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