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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033950
Receipt No. 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 2018/08/29

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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
Middle name
Last name Eiichi Nakamura
Organization Kumamoto University Medical Hospital
Division name Deaprtment of Orthopaedic Surgery
Zip code
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
Middle name
Last name Eiichi Nakamura
Organization Kumamoto University Medical Hospital
Division name Deaprtment of Orthopaedic Surgery
Zip code
Address 1-1-1, Honjyo, Chuo-ku, Kumamoto, 860-8556
TEL 096-373-5226
Homepage URL
Email h@kumamoto-u.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Kumamoto University Medical Hospital
Institute
Department

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
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

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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 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
2018 Year 08 Month 29 Day
Last modified on
2018 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.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


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