title: Shoulder Arthroplasty Trials Are Infrequently Registered: A Systematic Review of Trials.
abstract: BACKGROUND
  With the intent of improving transparency in clinical research, the International Committee of Medical Journal Editors (ICMJE) established guidelines in 2005 regarding prospective clinical trial registration. This action worked to address bias related to selective outcome reporting in the medical literature. The objective of this study was to assess and characterize the quality of registration of clinical trials appearing in shoulder arthroplasty-related medical journals.
  
  
  METHODS
  All randomized trials involving human subjects, pertaining to shoulder arthroplasty, published between July 1, 2005 and December 31, 2015, and indexed in either PubMed or SportDISCUS were analyzed. We assessed the prevalence of registration, the timing of registration relative to patient enrollment periods, and the variable rates of orthopedic journal compliance with ICMJE and Food and Drug Administration clinical registration standards for our study.
  
  
  RESULTS
  Of the 382 articles identified, 345 (90.3%) were excluded due to failure to meet inclusion criteria. From the remaining 37, only 12 (32.4%) studies were found to be registered in a trial registry. Ten (10/12, 83.3%) of these provided their registration information within the body of the article. None of the included studies from ICMJE-recognized journals were registered. From 34 included studies from non-ICMJE recognized journals, 12 (35.3%) were registered.
  
  
  CONCLUSIONS
  The level of compliance with clinical trial registration guidelines in the decade since their release among shoulder arthroplasty trials in orthopedic journals is poor. Given the importance of the issue, the prevalence of the problem, and the fact that many other medical specialties have already made efforts to improve ICMJE compliance, further work on the part of orthopedic surgery journal authors and editors is needed to ensure the publication of unbiased results.
  
  
  BACKGROUND
  UMIN000022487.
authors.affiliation: Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, United States of America.
authors.forename: Matthew Thomas
authors.identifier: http://orcid.org/0000-0001-8430-1983
authors.initials: MT
authors.lastname: Sims
authors.affiliation: Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, United States of America.
authors.forename: Zachary Carter
authors.initials: ZC
authors.lastname: Sanchez
authors.affiliation: Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, United States of America.|Oklahoma State University Medical Center, Tulsa, Oklahoma, United States of America.
authors.forename: James Murphy
authors.initials: JM
authors.lastname: Herrington
authors.affiliation: Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, United States of America.|Oklahoma State University Medical Center, Tulsa, Oklahoma, United States of America.
authors.forename: James Barrett
authors.initials: JB
authors.lastname: Hensel
authors.affiliation: Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, United States of America.
authors.forename: Nolan Michael
authors.initials: NM
authors.lastname: Henning
authors.affiliation: Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, United States of America.|Mayo Clinic, Phoenix, Arizona, United States of America.
authors.forename: Caleb Josiah
authors.initials: CJ
authors.lastname: Scheckel
authors.affiliation: Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, United States of America.
authors.forename: Matt
authors.initials: M
authors.lastname: Vassar
mesh_terms: D001178:Arthroplasty; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012042:Registries; D012782:Shoulder / Q000601:surgery*