UMIN-CTR Clinical Trial

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	Completed
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	2021 Year 10 Month 27 Day

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