UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Postoperative evaluations of imaging and functional outcome of unconstrained total elbow arthroplasty for destructive elbows in patients with rheumatid arthritis.
Title of the study (Brief title)	The clinical outcome of unconstrained total elbow arthroplasty for destructive elbows in patients with rheumatoid arthritis.
Region	Japan

Condition
Condition	Rheumatoid arthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical outcome (efficacy and safety) of unconstrained total elbow arthroplasty (Niigata-Senami-Kyocera modified;MNSK) for destructive elbows in patients with RA.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Preoperative and postoperative elbw functional score by Japanese Orthopedic Association, active range of motion of elbw joint(flexion, extension, pronation, and supination), the incidence of flexion contrcture, survivorship of the implant.
Key secondary outcomes	Complications such as infection, dislocation, and periprosthetic fractures.

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	15 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	RA patient fulfilled with RA diagnostic criteria by ACR 1987 and Larsen grade was up to grade 4.
Key exclusion criteria	Larsen grade 5, and high instability elbow, and infected elbow.
Target sample size	50

Research contact person
Name of lead principal investigator	Naoki Kondo
Organization	Niigata University Medical and Dental General Hospital
Division name	Orthopedc Surgery
Address	2-754, Asahimachi-dori, Chuo-Ku, Niigata
TEL	0252272272
Email	naokikondo1214@gmail.com

Public contact
Name of contact person	Naoki Kondo
Organization	Niigata University Medical and Dental General Hospital
Division name	Orthopedc Surgery
Address	2-754, Asahimachi-dori, Chuo-Ku, Niigata
TEL	0252272272
Homepage URL
Email	naokikondo1214@gmail.com

Sponsor
Institute	Division of Orthopedic SUrgery, Niigata University Medical and Dental General Hospital
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)

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	2019 Year 06 Month 30 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 03 Month 27 Day
Anticipated trial start date	2017 Year 03 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Already accepted in the journal

Management information
Registered date	2018 Year 12 Month 30 Day
Last modified on	2018 Year 12 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040271