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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007738
Receipt No. R000009116
Scientific Title Multi-center cohort study on the postoperative outcomes of Discovery total elbow arthroplasty
Date of disclosure of the study information 2012/04/13
Last modified on 2018/02/06

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Basic information
Public title Multi-center cohort study on the postoperative outcomes of Discovery total elbow arthroplasty
Acronym Cohort study of Discovery total elbow arthroplasty
Scientific Title Multi-center cohort study on the postoperative outcomes of Discovery total elbow arthroplasty
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiromu Ito
Organization Kyoto University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
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
1st name
Middle name
Last name Hiromu Ito
Organization Kyoto University Hospital
Division name Department of Orthopedic Surgery
Zip code
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)

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
2012 Year 04 Month 13 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 Preinitiation
Date of protocol fixation
2012 Year 04 Month 12 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000009116

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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