UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003151
Receipt number R000003821
Scientific Title Three-dimensional Kinematics during Deep Flexion Kneeling in Total Knee Arthroplasty : A prospective randomized study
Date of disclosure of the study information 2010/02/08
Last modified on 2013/02/08 19:41:28

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Basic information

Public title

Three-dimensional Kinematics during Deep Flexion Kneeling in Total Knee Arthroplasty : A prospective randomized study

Acronym

Three-dimensional Kinematics in Total Knee Arthroplasty

Scientific Title

Three-dimensional Kinematics during Deep Flexion Kneeling in Total Knee Arthroplasty : A prospective randomized study

Scientific Title:Acronym

Three-dimensional Kinematics in Total Knee Arthroplasty

Region

Japan


Condition

Condition

Osteoarthritis of the knee

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To measure the tibio-femoral kinematics and mobility of the PE mobile-bearing relative to the femoral and tibial components under weight-bearing conditions in a clinically representative cohort of patients implanted with rotating-platform mobile-bearing and fixed-bearing total knee arthroplasties

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

the tibio-femoral kinematics and mobility of the PE mobile-bearing relative to the femoral and tibial components under weight-bearing conditions

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


Dynamic allocation


Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Fourty knees of 40 patients will be enrolled in this study based on our selection criteria. At the surgery, 20 knees out of them will be implanted the fixed-bearing ultrahighmolecular -weight PE insert, while the remaining 20 knees with the mobile -bearing one.

Interventions/Control_2

Fluoroscopic images will be taken at 12 months following surgery during kneel, squat, and stair-climb activities.

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) the diagnosis of osteoarthritis of the knee
2) the flexion angle of the knee more than 120 degrees
3)primary TKA

Key exclusion criteria

Patients who
1)have severe systemic diseases contraindicated for total knee arthroplasty
2)have revision surgery

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Mizuta

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Department of Orthopaedic and Neuro-Musculoskeletal Surgery

Zip code


Address

1-1-1, Honjyo, Kumamoto-City, Kumamoto

TEL

096-373-5226

Email



Public contact

Name of contact person

1st name
Middle name
Last name Eiichi Nakamura

Organization

Kumamoto University Hospital

Division name

Department of Orthopaedic Surgery

Zip code


Address

1-1-1, Honjyo, Kumamoto-City, Kumamoto

TEL

096-373-5226

Homepage URL


Email

h@kumamoto-u.ac.jp


Sponsor or person

Institute

Department of Orthopaedic and Neuro-Musculoskeletal Surgery, Faculty of Life Sciences, Kumamoto University

Institute

Department

Personal name



Funding Source

Organization

Department of Orthopaedic and Neuro-Musculoskeletal Surgery, Faculty of Life Sciences, Kumamoto University

Organization

Division

Category of Funding Organization

Other

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

熊本大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2010 Year 02 Month 08 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

2010 Year 02 Month 08 Day

Date of IRB


Anticipated trial start date

2010 Year 02 Month 01 Day

Last follow-up date

2011 Year 12 Month 31 Day

Date of closure to data entry

2011 Year 12 Month 31 Day

Date trial data considered complete

2011 Year 12 Month 31 Day

Date analysis concluded

2012 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2010 Year 02 Month 08 Day

Last modified on

2013 Year 02 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003821


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name