Clinical Orthopaedics and Related Research®

, Volume 475, Issue 2, pp 532–539

High Irritation and Removal Rates After Plate or Nail Fixation in Patients With Displaced Midshaft Clavicle Fractures

  • Martijn H. J. Hulsmans
  • Mark van Heijl
  • R. Marijn Houwert
  • Eric R. Hammacher
  • Sven A. G. Meylaerts
  • Michiel H. J. Verhofstad
  • Marcel G. W. Dijkgraaf
  • Egbert J. M. M. Verleisdonk
Clinical Research

DOI: 10.1007/s11999-016-5113-8

Cite this article as:
Hulsmans, M.H.J., van Heijl, M., Houwert, R.M. et al. Clin Orthop Relat Res (2017) 475: 532. doi:10.1007/s11999-016-5113-8

Abstract

Background

Studies comparing plate with intramedullary nail fixation of displaced midshaft clavicle fractures show faster recovery in the plate group and implant-related complications in both groups after short-term followup (6 or 12 months). Knowledge of disability, complications, and removal rates beyond the first postoperative year will help surgeons in making a decision regarding optimal implant choice. However, comparative studies with followup beyond the first year or two are scarce.

Questions/purposes

We asked: (1) Does plate fixation or intramedullary nail fixation for displaced midshaft clavicle fractures result in less disability? (2) Which type of fixation, plate or intramedullary, is more frequently associated with implant-related irritation and implant removal? (3) Is plate or intramedullary fixation associated with postoperative complications beyond the first postoperative year?

Methods

Between January 2011 and August 2012, patients with displaced midshaft clavicle fractures were enrolled and randomized to plate or intramedullary nail fixation. A total of 58 patients with plate and 62 patients with intramedullary nails initially were enrolled. Minimum followup was 30 months (mean, 39 months; range, 30–51 months). Two patients (3%) with plate fixation and two patients (3%) with intramedullary nails were lost to followup. The QuickDASH was obtained at final followup and compared between patients who had plate fixation and those who had intramedullary nail fixation. Postoperative complications measured include infection, implant-related irritation, implant failure, nonunion, and refracture after implant removal. Indications for implant removal included implant-related irritation, implant failure, nonunion, patient’s wish, or surgeon’s preference.

Results

Between patients with plate versus intramedullary nail fixation, there were no differences in QuickDASH scores (plate, 1.8 ± 3.6; intramedullary nail, 1.8 ± 7.2; mean difference, −0.7; 95% CI, −2.2 to 2.04; p = 0.95). The proportion of patients having implant-related irritation was not different (39 of 56 [70%] versus 41 of 62 [66%]; relative risk, 1.05; 95% CI, 0.82–1.35; p = 0.683). Intramedullary fixation was associated with a higher likelihood of implant removal (51 of 62 [82%] versus 28 of 56 [50%]; relative risk, 1.65; 95% CI, 1.24–2.19; p < 0.001). Among the removed implants more plates than intramedullary nails were removed after the 1-year followup (12 of 28 [43%] versus six of 51 [12%]; p = 0.002). There were no infections, implant breakage, nonunions, or refractures between the 1-year and final followup in either group.

Conclusions

After a mean followup of 39 months, disability scores were excellent. Major complications did not occur after the 1-year followup. A frequent and bothersome problem after both surgical treatments is implant-related irritation, resulting in high rates of implant removal, after 1 year. Future research could focus on analyzing risk factors for implant irritation or removal.

Level of Evidence

Level II, therapeutic study.

Copyright information

© The Association of Bone and Joint Surgeons® 2016

Authors and Affiliations

  • Martijn H. J. Hulsmans
    • 1
  • Mark van Heijl
    • 1
  • R. Marijn Houwert
    • 2
  • Eric R. Hammacher
    • 3
  • Sven A. G. Meylaerts
    • 4
  • Michiel H. J. Verhofstad
    • 5
  • Marcel G. W. Dijkgraaf
    • 6
  • Egbert J. M. M. Verleisdonk
    • 1
  1. 1.Department of SurgeryDiakonessenhuis UtrechtUtrechtThe Netherlands
  2. 2.Utrecht TraumacenterUtrechtThe Netherlands
  3. 3.Department of SurgerySt Antonius HospitalNieuwegeinThe Netherlands
  4. 4.Department of SurgeryMedical Center HaaglandenThe HagueThe Netherlands
  5. 5.Trauma Research Unit Department of Surgery, Erasmus Medical CentreUniversity Medical Center RotterdamRotterdamThe Netherlands
  6. 6.Clinical Research Unit, Academic Medical Center AmsterdamAmsterdamThe Netherlands