UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multi-center cohort study on the postoperative outcomes of Discovery total elbow arthroplasty
Title of the study (Brief title)	Cohort study of Discovery total elbow arthroplasty
Region	Japan

Condition
Condition	elbow arthropathy
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To observe the efficacy and safety of total elbow arthroplasty using Discovery total elbow by multi-center cohort study in Japan
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MEPS, radiological loosening, ratios of revision after 3 years
Key secondary outcomes	ratios of operative complications, disease activity for rheumatoid arthritis patients (DAS28, SDAI)

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	Patients with elbow arthropathy with 1) radiological joint destruction (Larsen grade 3 or above) and ADL disability in RA patients, or 2) radiological joint destruction (K-L grade 3 or above) and ADL disability in OA patients
Key exclusion criteria	1) severe neurological symptoms in the upper limb 2) cognitive conditions 3) fracture of the elbow 4) conditions more suitable for other elbow arhthrplasties 5) revision arthroplasty
Target sample size	50

Research contact person
Name of lead principal investigator	Hiromu Ito
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Address	54 Kawahara-cho, Shogoin,Sakyo, Kyoto 606-8507, Japan
TEL	075-751-3877
Email	hiromu@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Hiromu Ito
Organization	Kyoto University Hospital
Division name	Department of Orthopedic Surgery
Address	54 Kawahara-cho, Shogoin,Sakyo, Kyoto 606-8507, Japan
TEL	075-751-3877
Homepage URL
Email	hiromu@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital, Department of Orthopaedic Surgery
Institute
Department

Funding Source
Organization	BMS, Ono
Organization
Division
Category of Funding Organization	Profit organization
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	2012 Year 04 Month 13 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2012 Year 04 Month 12 Day
Anticipated trial start date	2012 Year 04 Month 01 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	Unpublished
URL releasing results
Results
Other related information	1) preoperative conditions including MEPS, ROM, ADL disabilities, disease activity and radiological evaluations 2) duration of the operation, blood loss, fixation period 3) periopertive complications 4) postoperative conditions including MEPS, ROM, ADL disabilities, disease activity and radiological evaluations

Management information
Registered date	2012 Year 04 Month 13 Day
Last modified on	2018 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009116