UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033950
Receipt number R000038721
Scientific Title Comparative study in three-dimensional tibiofemoral kinematics during mid flexion lunge in a PCL substituting TKA for knee osteoarthritis
Date of disclosure of the study information 2018/09/01
Last modified on 2022/09/02 08:07:09

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Basic information

Public title

Comparative study in three-dimensional tibiofemoral kinematics during mid flexion lunge in a PCL substituting TKA for knee osteoarthritis

Acronym

3-D tibiofemoral kinematics during mid flexion lunge in a PCL substituting TKA

Scientific Title

Comparative study in three-dimensional tibiofemoral kinematics during mid flexion lunge in a PCL substituting TKA for knee osteoarthritis

Scientific Title:Acronym

3-D tibiofemoral kinematics during mid flexion lunge in a PCL substituting TKA

Region

Japan


Condition

Condition

Osteoarthritis of the knee

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the diffrerences in three dimentional tibiofemoral kinematics during mid flexion lunge between a posterior-stabilized and a cruciate-substituting total knee arthroplasty in a prospective randomized trial

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.Patient-based clinical evaluation
2.ragiographic evaluation
3.kinematics analysis using the 2D/3D image registration technique

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Total Knee Arthroplasty

Interventions/Control_2

Radiographic evalaution before and six moths after surgery

Interventions/Control_3

Kinematic analysisusing the 2D/3D image matching technique at six moths after surgery

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. Medial ostoarthritis of unilateral or both knees
2. The patients who agreed the informed consent of participation in this study

Key exclusion criteria

1. The patients underwent the previou surgery in the involved limb
2. The patient with previous osteomyelitis
3. Active flexion angle of the knee less than 120 degrees
4. The patient who refused the participation of this study

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Eiichi
Middle name
Last name Nakamura

Organization

Kumamoto University Medical Hospital

Division name

Deaprtment of Orthopaedic Surgery

Zip code

860-8556

Address

1-1-1, Honjyo, Chuo-ku, Kumamoto, 860-8556

TEL

096-373-5226

Email

h@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name Eiichi
Middle name
Last name Nakamura

Organization

Kumamoto University Medical Hospital

Division name

Deaprtment of Orthopaedic Surgery

Zip code

860-8556

Address

1-1-1, Honjyo, Chuo-ku, Kumamoto, 860-8556

TEL

096-373-5226

Homepage URL


Email

h@kumamoto-u.ac.jp


Sponsor or person

Institute

Department of Orthopaedic Surgery, Kumamoto University Medical Hospital

Institute

Department

Personal name



Funding Source

Organization

MicroPort Orthopedics Inc.,
5677 Airline Road, Arlington, TN 38002, U.S.A.

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

U.S.A.


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Research Board

Address

1-1-1 Honjo, Chuo-ku, Kumamoto-City, Kumamoto, 8508556, Japan

Tel

096-373-5966

Email

byi-senshin@jimu.kumamoto-u.ac.jp


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



Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 01 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

No longer recruiting

Date of protocol fixation

2018 Year 08 Month 07 Day

Date of IRB

2018 Year 08 Month 07 Day

Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 29 Day

Last modified on

2022 Year 09 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038721


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name