UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007738 |
|---|---|
| Receipt number | 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 23:20:10 |
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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
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
hiromu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital, Department of Orthopaedic Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009116
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
