title: Open reduction and plate fixation versus nonoperative treatment for displaced midshaft clavicular fractures: a multicenter, randomized, controlled trial.
abstract: BACKGROUND
  There is a growing trend to treat displaced midshaft clavicular fractures with primary open reduction and plate fixation; whether such treatment results in improved patient outcomes is debatable. The aim of this multicenter, single-blinded, randomized controlled trial was to compare union rates, functional outcomes, and economic costs for displaced midshaft clavicular fractures that were treated with either primary open reduction and plate fixation or nonoperative treatment.
  
  
  METHODS
  In a prospective, multicenter, stratified, randomized controlled trial, 200 patients between sixteen and sixty years of age who had an acute displaced midshaft clavicular fracture were randomized to receive either primary open reduction and plate fixation or nonoperative treatment. Functional assessment was conducted at six weeks, three months, six months, and one year with use of the Disabilities of the Arm, Shoulder and Hand (DASH) and Constant scores. Union was evaluated with use of three-dimensional computed tomography. Complications were recorded, and an economic evaluation was performed.
  
  
  RESULTS
  The rate of nonunion was significantly reduced after open reduction and plate fixation (one nonunion) as compared with nonoperative treatment (sixteen nonunions) (relative risk = 0.07; p = 0.007). Group allocation to nonoperative treatment was independently predictive of the development of nonunion (p = 0.0001). Overall, DASH and Constant scores were significantly better after open reduction and plate fixation than after nonoperative treatment at the time of the one-year follow-up (DASH score, 3.4 versus 6.1 [p = 0.04]; Constant score, 92.0 versus 87.8 [p = 0.01]). However, when patients with nonunion were excluded from analysis, there were no significant differences in the Constant scores or DASH scores at any time point. Patients were less dissatisfied with symptoms of shoulder droop, local bump at the fracture site, and shoulder asymmetry in the open reduction and plate fixation group (p < 0.0001). The cost of treatment was significantly greater after open reduction and plate fixation (p < 0.0001).
  
  
  CONCLUSIONS
  Open reduction and plate fixation reduces the rate of nonunion after acute displaced midshaft clavicular fracture compared with nonoperative treatment and is associated with better functional outcomes. However, the improved outcomes appear to result from the prevention of nonunion by open reduction and plate fixation. Open reduction and plate fixation is more expensive and is associated with implant-related complications that are not seen in association with nonoperative treatment. The results of the present study do not support routine primary open reduction and plate fixation for the treatment of displaced midshaft clavicular fractures.
authors.affiliation: The Edinburgh Shoulder Clinic, The New Royal Infirmary of Edinburgh, Little France, Edinburgh EH16 4SU, United Kingdom. c.mike.robinson@ed.ac.uk
authors.forename: C M
authors.initials: CM
authors.lastname: Robinson
authors.forename: E B
authors.initials: EB
authors.lastname: Goudie
authors.forename: I R
authors.initials: IR
authors.lastname: Murray
authors.forename: P J
authors.initials: PJ
authors.lastname: Jenkins
authors.forename: M A
authors.initials: MA
authors.lastname: Ahktar
authors.forename: E O
authors.initials: EO
authors.lastname: Read
authors.forename: C J
authors.initials: CJ
authors.lastname: Foster
authors.forename: K
authors.initials: K
authors.lastname: Clark
authors.forename: A J
authors.initials: AJ
authors.lastname: Brooksbank
authors.forename: A
authors.initials: A
authors.lastname: Arthur
authors.forename: M A
authors.initials: MA
authors.lastname: Crowther
authors.forename: I
authors.initials: I
authors.lastname: Packham
authors.forename: T J
authors.initials: TJ
authors.lastname: Chesser
mesh_terms: D000293:Adolescent; D000328:Adult; D001860:Bone Plates; D002968:Clavicle / Q000000981:diagnostic imaging / Q000293:injuries* / Q000601:surgery; D005260:Female; D005592:Fracture Fixation / Q000379:methods*; D017102:Fracture Healing / Q000502:physiology*; D050723:Fractures, Bone / Q000000981:diagnostic imaging / Q000601:surgery / Q000628:therapy*; D005599:Fractures, Ununited / Q000000981:diagnostic imaging / Q000601:surgery / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009984:Orthopedic Fixation Devices; D011859:Radiography; D016059:Range of Motion, Articular; D020127:Recovery of Function; D016896:Treatment Outcome