title: Plate fixation of midshaft clavicular fractures: patient-reported outcomes and hardware-related complications.
abstract: BACKGROUND
  Recent studies report high hardware removal rates after plate fixation of midshaft clavicular fractures. Precontoured clavicle plates may decrease hardware-related complications while improving healing rates and patient-reported outcomes (PROs).
  
  
  METHODS
  Using a private-payer national database, we identified 7826 patients who underwent clavicle open reduction and internal fixation (ORIF) in 2007 to 2011. Database patients were tracked for 2 years to assess hardware removal and revision fixation. In addition, we retrospectively identified 73 patients who underwent plate fixation of midshaft clavicular fractures at our institution. These patients completed the Disabilities of Arm, Shoulder and Hand (DASH) assessment, the EQ-5D (EuroQol, Rotterdam, The Netherlands) quality of life assessment, and a hardware-related outcomes survey.
  
  
  RESULTS
  Among 7826 database patients, 994 (12.7%) underwent hardware removal and 78 (1%) required revision ORIF. The annual incidence of clavicle ORIF increased 61.5% between 2007 and 2011. In our institutional cohort, 56 patients (77%) were fixed with precontoured plates and 17 (23%) with standard plates. At a mean follow-up of 4.2 years, 11 patients (15%) underwent hardware removal and 1 patient (1.4%) experienced nonunion. Patients reported excellent outcomes, with average DASH of 4.0 ± 8.9 and EQ-5D of 0.89 ± 0.19. There were no differences in PROs, hardware removal, or union rate between plate types, although our study was underpowered for these outcomes. Patients who underwent hardware removal reported lower DASH, EQ-5D, satisfaction, and shoulder function compared with patients with hardware retained. Women were more likely to undergo hardware removal in the institutional (P = .009) and the database (P < .001) cohorts.
  
  
  CONCLUSIONS
  Displaced midshaft clavicle fractures have high union rates with precontoured plate fixation. Women are 4 times more likely than men to have hardware removed. Patients undergoing clavicle hardware removal report worse long-term outcomes than patients with hardware retained.
authors.affiliation: Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA, USA.
authors.forename: Micah
authors.initials: M
authors.lastname: Naimark
authors.affiliation: Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA, USA.
authors.forename: Faustine L
authors.initials: FL
authors.lastname: Dufka
authors.affiliation: Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Han
authors.affiliation: Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA, USA.
authors.forename: David C
authors.initials: DC
authors.lastname: Sing
authors.affiliation: Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Toogood
authors.affiliation: Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA, USA.
authors.forename: C Benjamin
authors.initials: CB
authors.lastname: Ma
authors.affiliation: Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA, USA.
authors.forename: Alan L
authors.initials: AL
authors.lastname: Zhang
authors.affiliation: Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA, USA. Electronic address: feeleyb@orthosurg.ucsf.edu.
authors.forename: Brian T
authors.initials: BT
authors.lastname: Feeley
mesh_terms: D000293:Adolescent; D000328:Adult; D001860:Bone Plates / Q000009:adverse effects*; D002648:Child; D002968:Clavicle / Q000293:injuries*; D020878:Device Removal; D018483:Diaphyses / Q000293:injuries / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D005593:Fracture Fixation, Internal / Q000009:adverse effects / Q000295:instrumentation*; D017102:Fracture Healing; D050723:Fractures, Bone / Q000601:surgery*; D005599:Fractures, Ununited / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D000070799:Open Fracture Reduction; D000071066:Patient Reported Outcome Measures; D011474:Prosthesis Design / Q000009:adverse effects; D011788:Quality of Life; D012086:Reoperation; D012189:Retrospective Studies; D011795:Surveys and Questionnaires; D055815:Young Adult
keywords: Clavicle fracture; hardware removal; national database; nonunion; patient-reported outcomes; plate fixation; precontoured plates