UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022487 |
|---|---|
| Receipt number | R000025913 |
| Scientific Title | Shoulder arthroplasty trials are infrequently registered: a systematic review of trials |
| Date of disclosure of the study information | 2016/05/27 |
| Last modified on | 2016/06/29 05:04:40 |
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Basic information
Public title
Shoulder arthroplasty trials are infrequently registered: a systematic review of trials
Acronym
Infrequent trial registration in shoulder arthroplasty trials
Scientific Title
Shoulder arthroplasty trials are infrequently registered: a systematic review of trials
Scientific Title:Acronym
Infrequent trial registration in shoulder arthroplasty trials
Region
| North America |
Condition
Condition
Clinical Trial Registration
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of our project is to investigate clinical trial registration of shoulder arthroplasty studies between July 1, 2005 and December 31, 2015.
Basic objectives2
Others
Basic objectives -Others
To examine shoulder arthroplasty trials for trial registration numbers and, if unavailable, three common public trial registry platforms (ClinicalTrials.gov, WHO, and ISRCTN).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Are trial registration identification numbers listed within the text of shoulder arthroplasty publications?
Key secondary outcomes
2. If #1 is unknown, are published shoulder arthroplasty studies able to be found on ClinicalTrials.gov, WHO, and ISRCTN registry platforms?
3. If #2 is unknown, is the corresponding author able to provide the trial registration identification number?
4. Are studies (registered or unregistered) published in ICMJE recognized or non-ICMJE recognized journals?
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Studies including:
1.RCTs
2.RCTs that utilize a crossover method
3.Follow-up on previously performed RCTs that are analyzing different primary outcomes that were published in the journals between July 1, 2005 and December 31, 2015.
Key exclusion criteria
All other study designs were excluded including:
1. Observational studies (including cohort, case-control, and cross sectional)
2. Systematic reviews/Meta-analyses
3. Ongoing studies
4. Commentary or discussion pieces
5. Articles with only a title or lacking an abstract
6. Simulation-based studies
7. Animal/ in vitro studies
8. Cadaver studies
9. Studies not examining shoulder arthroplasty interventions
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Matthew Thomas Sims |
Organization
Oklahoma State University Center for Health Sciences
Division name
College of Osteopathic Medicine
Zip code
Address
1111 W 17th St, Tulsa, OK 74107 USA
TEL
918-582-1972
matt.sims@okstate.edu
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Matthew Thomas Sims |
Organization
Oklahoma State University Center for Health Sciences
Division name
College of Osteopathic Medicine
Zip code
Address
1111 W 17th St, Tulsa, OK 74107 USA
TEL
918-582-1972
Homepage URL
http://www.healthsciences.okstate.edu
matt.sims@okstate.edu
Sponsor or person
Institute
Oklahoma State University Center for Health Sciences - College of Osteopathic Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
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
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
| 2016 | Year | 05 | Month | 27 | 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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 07 | Month | 01 | Day |
Other
Other related information
Systematic Review
Management information
Registered date
| 2016 | Year | 05 | Month | 27 | Day |
Last modified on
| 2016 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025913
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
