title: Rationale and design of the plate or pin (POP) study for dislocated midshaft clavicular fractures: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  To describe the rationale and design of a future study comparing results of plate fixation and Elastic Stable Intramedullary Nailing (ESIN) with a Titanium Elastic Nail (TEN) for adults with a dislocated midshaft clavicular fracture.
  
  
  METHODS
  Prospective randomized multicenter clinical trial in two level 1 and one level 2 trauma centers. 120 patients between 18 and 65 years of age will be included. They are randomized to either plate fixation or ESIN with a TEN with a one year follow-up. Sixty patients will be treated with plate fixation and 60 patients will be treated with ESIN. Primary outcome parameter is the Disabilities of the Arm, Shoulder and Hand score after 6 months. Secondary outcome parameters are Constant Shoulder Score, complications, experienced pain, radiologic consolidation and cosmetics after both procedures.
  
  
  CONCLUSIONS
  Prospective randomized studies comparing operative techniques for treatment of dislocated midshaft clavicular fracture are lacking. By studying shoulder function, complications, quality of life, radiographic union, cosmetics as well as experienced pain, a complete efficacy assessment of both procedures will be performed.
  
  
  BACKGROUND
  The POP study is registered in the Dutch Trial Register (NTR NTR2438).
authors.affiliation: Department of Surgery, Diakonessenhuis, Utrecht, The Netherlands. fjgwijdicks@gmail.com
authors.forename: Frans J G
authors.initials: FJ
authors.lastname: Wijdicks
authors.forename: R Marijn
authors.initials: RM
authors.lastname: Houwert
authors.forename: Marcel G W
authors.initials: MG
authors.lastname: Dijkgraaf
authors.forename: Diederik H
authors.initials: DH
authors.lastname: De Lange
authors.forename: Sven A G
authors.initials: SA
authors.lastname: Meylaerts
authors.forename: Michiel H J
authors.initials: MH
authors.lastname: Verhofstad
authors.forename: Egbert J J M
authors.initials: EJ
authors.lastname: Verleisdonk
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001858:Bone Nails; D001860:Bone Plates; D002968:Clavicle / Q000000981:diagnostic imaging / Q000293:injuries / Q000601:surgery*; D004185:Disability Evaluation; D005260:Female; D005593:Fracture Fixation, Internal / Q000009:adverse effects / Q000295:instrumentation*; D005594:Fracture Fixation, Intramedullary / Q000009:adverse effects / Q000295:instrumentation*; D017102:Fracture Healing; D050723:Fractures, Bone / Q000175:diagnosis / Q000000981:diagnostic imaging / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D010147:Pain Measurement; D010149:Postoperative Pain / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D012107:Research Design; D012783:Shoulder Dislocation / Q000175:diagnosis / Q000000981:diagnostic imaging / Q000601:surgery*; D013997:Time Factors; D014025:Titanium; D014193:Trauma Centers; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014025:Titanium