UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Shoulder arthroplasty trials are infrequently registered: a systematic review of trials
Title of the study (Brief title)	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?

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Matthew Thomas Sims
Organization	Oklahoma State University Center for Health Sciences
Division name	College of Osteopathic Medicine
Address	1111 W 17th St, Tulsa, OK 74107 USA
TEL	918-582-1972
Email	matt.sims@okstate.edu

Public contact
Name of contact person	Matthew Thomas Sims
Organization	Oklahoma State University Center for Health Sciences
Division name	College of Osteopathic Medicine
Address	1111 W 17th St, Tulsa, OK 74107 USA
TEL	918-582-1972
Homepage URL	http://www.healthsciences.okstate.edu
Email	matt.sims@okstate.edu

Sponsor
Institute	Oklahoma State University Center for Health Sciences - College of Osteopathic Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025913