Operative treatment of displaced midshaft clavicle fractures: has randomised control trial evidence changed practice patterns?

Objectives To determine if level 1 evidence from a landmark trial changed practice patterns for treatment of patients with displaced midshaft clavicle fractures. Design Retrospective cohort study. Setting Two level 1 trauma centres. Participants Displaced midshaft clavicle fractures. Results 686 patients met inclusion criteria. The pretrial cohort (n=108) was 68.5% male, with a mean age of 37.7 (±13.9) years. The post-trial cohort (n=578) was 76.1% male, with a mean age of 41.9 (±12.7) years. There was nearly a 10-fold increase in the patients treated with openreduction and internal fixation (ORIF) in the post-trial cohort (34.1%) compared with the pretrial cohort (3.7%) (p<0.001). Patients in the post-trial cohort were more likely to undergo ORIF if they were <40 years (OR=2.2; 95% CI 1.53 to 3.10), if their Injury Severity Score was >9 (OR=1.6; 95% CI 0.89 to 2.99) or if they were treated at a centre that participated in the Canadian Orthopaedic Trauma Society ( COTS ) trial (OR=5.2; 95% CI 3.31 to 8.21). Conclusions This study demonstrated a significant shift towards more frequent ORIF for displaced midshaft clavicle fractures following the COTS trial. Quantifying changes in practice pattern following publication of level 1 evidence is important to further our understanding of the impact large randomised clinical trails are having on clinical practice.

[1]  S. Zaffagnini,et al.  Midshaft Clavicle Fractures: Surgery Provides Better Results as Compared With Nonoperative Treatment: A Meta-analysis , 2019, The American journal of sports medicine.

[2]  S. Jaglal,et al.  Practice patterns in the care of acute Achilles tendon ruptures: IS THERE AN ASSOCIATION WITH LEVEL I EVIDENCE? , 2017, The bone & joint journal.

[3]  A. Rangan,et al.  Impact of the PROFHER trial findings on surgeons’ clinical practice , 2017, Bone & joint research.

[4]  V. Lepola,et al.  Trends in the Incidence of Clavicle Fractures and Surgical Repair in Sweden: 2001-2012. , 2016, The Journal of bone and joint surgery. American volume.

[5]  R. Brydges,et al.  Development and Assessment of a Distal Radial Fracture Model as a Clinical Teaching Tool. , 2016, The Journal of bone and joint surgery. American volume.

[6]  M. Costa,et al.  Do large pragmatic randomised trials change clinical practice?: assessing the impact of the Distal Radius Acute Fracture Fixation Trial (DRAFFT). , 2016, The bone & joint journal.

[7]  M. Bhandari,et al.  The Influence of Large Clinical Trials in Orthopedic Trauma: Do They Change Practice? , 2013, Journal of orthopaedic trauma.

[8]  B. Snyder,et al.  Changing Practice Patterns: The Impact of a Randomized Clinical Trial on Surgeons Preference for Treatment of Type 3 Supracondylar Humerus Fractures , 2012, Journal of pediatric orthopedics.

[9]  M. McKee,et al.  Operative versus nonoperative care of displaced midshaft clavicular fractures: a meta-analysis of randomized clinical trials. , 2012, The Journal of bone and joint surgery. American volume.

[10]  S. Adie,et al.  Practice variation in common fracture presentations: a survey of orthopaedic surgeons. , 2011, Injury.

[11]  A. Tosteson,et al.  Is Surgery for Displaced, Midshaft Clavicle Fractures in Adults Cost-Effective? Results Based on a Multicenter Randomized, Controlled Trial , 2010, Journal of orthopaedic trauma.

[12]  M. Bhandari,et al.  Can orthopedic trials change practice? , 2010, Acta orthopaedica.

[13]  M. McKee,et al.  Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. Surgical technique. , 2008, The Journal of bone and joint surgery. American volume.

[14]  M. McKee,et al.  Treatment of Acute Midshaft Clavicle Fractures: Systematic Review of 2144 Fractures: On behalf of the Evidence-Based Orthopaedic Trauma Working Group , 2005, Journal of orthopaedic trauma.

[15]  Jan Nowak,et al.  Sequelae from clavicular fractures are common , 2005, Acta orthopaedica.

[16]  L A Crosby,et al.  Closed treatment of displaced middle-third fractures of the clavicle gives poor results. , 1997, The Journal of bone and joint surgery. British volume.

[17]  C. Rowe.  An atlas of anatomy and treatment of midclavicular fractures. , 1968, Clinical orthopaedics and related research.

[18]  C. Neer.  Nonunion of the clavicle. , 1960, Journal of the American Medical Association.

[19]  M. Swiontkowski.  Nonoperative Treatment Compared with Plate Fixation of Displaced Midshaft Clavicular Fractures. A Multicenter, Randomized Clinical Trial , 2008 .

[20]  Lv Ming.  Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures , 2007 .

[21]  L. Audigé,et al.  Fracture and Dislocation Classification Compendium - 2007 Orthopaedic Trauma Association Classification, Database and Outcomes Committee , 2007 .

[22]  M. Bosse.  CAQ: Orthopaedic Trauma "Damage Control". , 2007, Journal of orthopaedic trauma.

[23]  Joseph Bernstein,et al.  Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. , 2007, The Journal of bone and joint surgery. American volume.

[24]  Emil H Schemitsch,et al.  Deficits following nonoperative treatment of displaced midshaft clavicular fractures. , 2006, The Journal of bone and joint surgery. American volume.

[25]  E. Antman,et al.  Trends in the use of pharmacotherapies for acute myocardial infarction among physicians who design and/or implement randomized trials versus physicians in routine clinical practice: the MILIS-TIMI experience. Multicenter Investigation on Limitation of Infarct Size. Thrombolysis in Myocardial Infarct , 1999, American heart journal.