UMIN-CTR Clinical Trial

Basic information
Public title	The verification study on correlative relationship between bone resection volume and outcomes in the TKA with .Triathlon CR/PS and Advanced-Gap-Sezer.
Acronym	Triathlon & AGS Study
Scientific Title	The verification study on correlative relationship between bone resection volume and outcomes in the TKA with .Triathlon CR/PS and Advanced-Gap-Sezer.
Scientific Title:Acronym	Triathlon & AGS Study
Region	Japan

Condition
Condition	Knee osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the efficacy on outcomes of TKA using Triathlon Knee system which is single radius design by accurate bone resection.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Radiographic evaluation. Functional Score. Patients satisfaction.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients are candidate for primary TKA. 2) Patients have diagnosis of OA. 3) Patients are age 20 or over. 4) Patient, who can walk independently without assistance person. 5) Patients, who agree on an IRB-approved, study specific Informed Patient Consent Form 6) Patients are willing and able to comply with postoperative scheduled evaluations
Key exclusion criteria	1) Patients have bacterial infectious disease or have risk highly of bacterial infection. 2) Patients requiring revision surgery. 3) Patients, who are severe Baker's leg (FTA < 165 degree). 4) Patients had bone osteotomy to tibia. 5) Patients, who are morbidly obese, defined as having a Body Mass Index (BMI) > 40. 6) Patients who is pregnant female or maybe so. 7) Patients who have a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device. 8) Patients with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy). 9) Patients who are immunologically suppressed or receiving chronic steroids. 10) Patients who are judged ineligible with reasonable reason by primary doctor.
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazue Hayakawa
Organization	Fujita Health University
Division name	Graduate School of Medicine
Zip code
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN
TEL	0562-93-2635
Email	hkazue@fujita-hu.ac.jp

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, 112-0004 Japan
TEL	03-6894-8219
Homepage URL
Email	satoru.motohashi@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	2016 Year 06 Month 06 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	208
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	2015 Year 10 Month 16 Day
Date of IRB	2016 Year 03 Month 11 Day
Anticipated trial start date	2016 Year 05 Month 19 Day
Last follow-up date	2020 Year 04 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multi-center, Prospective, Observational research (non-intervention, minimal invasive)

Management information
Registered date	2016 Year 05 Month 31 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=R000025994