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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027849
Receipt No. R000031599
Scientific Title The effect of component gap balance on post-operative patient satisfaction and functional outcomes in primary total knee arthroplasty
Date of disclosure of the study information 2017/06/21
Last modified on 2019/06/24

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Basic information
Public title The effect of component gap balance on post-operative patient satisfaction and functional outcomes in primary total knee arthroplasty
Acronym The effect of component gap balance on post-operative patient satisfaction and functional outcomes in primary total knee arthroplasty
Scientific Title The effect of component gap balance on post-operative patient satisfaction and functional outcomes in primary total knee arthroplasty
Scientific Title:Acronym The effect of component gap balance on post-operative patient satisfaction and functional outcomes in primary total knee arthroplasty
Region
Japan

Condition
Condition Osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of medial component gap difference between extension and flexion for post-operative patient satisfaction and functional outcomes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the effect of medial component gap difference between extension and flexion for post-operative patient satisfaction and functional outcomes
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.The subject requires a primary total knee replacement
2.The subject is between 20 years old to 80 years old
3.The subject is diagnosed as osteoarthritis
4.The subject has intact collateral ligament
5.The subject has signed the IRB approved, study specific informed patient consent form
6.The subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation
Key exclusion criteria 1.The subject is pregnant
2.The subject has inflammatory arthritis
3.The subject is morbidly obese
4.The subject has had unicompartmental arthroplasty, high tibial osteotomy, femoral osteotomy and/or joint fusion
5.The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device
6.The subject has a systemic or metabolic disorder leading to progressive bone deterioration
7.The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements
8.The patient has a deformity which will require the use of stems, wedges or augments
9.The subject has an active or suspected latent infection in or about the knee joint
10.The patient who are inappropriate for participating in the study in the judgment of the investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Takagi
Organization Showa University Fujigaoka Hospital
Division name Orthopaedics
Zip code
Address 1-30, Fujigaoka, Aoba-ku, Yokohama, Kanagawa Pref.
TEL 045-971-1151
Email izn00067@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Motohashi
Organization Stryker Japan K.K.
Division name Clinical Affairs
Zip code
Address 2-6-1, Koraku, Bunkyo-ku, Tokyo
TEL 03-6894-8394
Homepage URL
Email NSKclinicaltrial@stryker.com

Sponsor
Institute Stryker Japan K.K.
Institute
Department

Funding Source
Organization Stryker Japan K.K.
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 21 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
2017 Year 03 Month 14 Day
Date of IRB
2017 Year 04 Month 17 Day
Anticipated trial start date
2017 Year 06 Month 10 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate medial gap difference between flextion-extension and post clinical outcome in TKA subject with Triathlon total knee system.

Management information
Registered date
2017 Year 06 Month 21 Day
Last modified on
2019 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031599

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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