UMIN-CTR Clinical Trial

Basic information
Public title	Accuracy of Patient Specific Instrumentation in Total Knee Arthroplasty
Acronym	Accuracy of Patient Specific Instrumentation in Total Knee Arthroplasty
Scientific Title	Accuracy of Patient Specific Instrumentation in Total Knee Arthroplasty
Scientific Title:Acronym	Accuracy of Patient Specific Instrumentation in Total Knee Arthroplasty
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 accuracy of patient specific instrumentation in total knee arthroplasty
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	accuracy of postoperative alignment accuracy of the intraoperative registration
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Use the patient specific instrumentation
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	the patients with osteoarthritis or rheumatoid arthritis who are need total knee arthroplasty
Key exclusion criteria	the patients with with inflammatory disease, trauma nor surgical history
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Ken Middle name Last name Okazaki
Organization	Kyushu University
Division name	Department of Orthopaedic Surgery
Zip code	812-8582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5488
Email	okazaki@ortho.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Hideki Middle name Last name Mizu-uchi
Organization	Kyushu University
Division name	Department of Orthopaedic Surgery
Zip code	812-8582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5488
Homepage URL
Email	himizu@ortho.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Center for Clinical and Translational Research of Kyushu University Hospital
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel	092-642-5774
Email	tr-info@med.kyushu-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	2015 Year 05 Month 11 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/28888738/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/28888738/
Number of participants that the trial has enrolled	18
Results	Article was published
Results date posted	2022 Year 11 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	18 knees
Participant flow	no problem
Adverse events	none
Outcome measures	radiological outcome functional outcome
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 11 Day
Date of IRB	2013 Year 11 Month 11 Day
Anticipated trial start date	2013 Year 11 Month 12 Day
Last follow-up date	2017 Year 03 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	2015 Year 05 Month 10 Day
Last modified on	2022 Year 11 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020265