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


OBJECTIVE
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.


METHODS
Level II, therapeutic study.
Department of Surgery, Diakonessenhuis Utrecht, PO Box 80250, 3508 TG, Utrecht, The Netherlands.
Martijn H J
MH
Hulsmans
Department of Surgery, Diakonessenhuis Utrecht, PO Box 80250, 3508 TG, Utrecht, The Netherlands.
Mark
M
van Heijl
Utrecht Traumacenter, Utrecht, The Netherlands.
R Marijn
RM
Houwert
Department of Surgery, St Antonius Hospital, Nieuwegein, The Netherlands.
Eric R
ER
Hammacher
Department of Surgery, Medical Center Haaglanden, The Hague, The Netherlands.
Sven A G
SA
Meylaerts
Trauma Research Unit Department of Surgery, Erasmus Medical Centre, University Medical Center Rotterdam, Rotterdam, The Netherlands.
Michiel H J
MH
Verhofstad
Clinical Research Unit, Academic Medical Center Amsterdam, Amsterdam, The Netherlands.
Marcel G W
MG
Dijkgraaf
Department of Surgery, Diakonessenhuis Utrecht, PO Box 80250, 3508 TG, Utrecht, The Netherlands. ejverleisdonk@gmail.com.
Egbert J M M
EJ
Verleisdonk
D000328:Adult; D001858:Bone Nails; D001860:Bone Plates; D002968:Clavicle / Q000293:injuries* / Q000601:surgery; D005260:Female; D005593:Fracture Fixation, Internal / Q000379:methods*; D005594:Fracture Fixation, Intramedullary / Q000379:methods; D050723:Fractures, Bone / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D020127:Recovery of Function; D012086:Reoperation; D016896:Treatment Outcome