Plate fixation compared with nonoperative treatment of displaced midshaft clavicular fractures: a randomized clinical trial

Abstract

Aims Recent studies of nonoperatively treated displaced midshaft clavicular fractures have shown a high incidence of nonunion and unsatisfactory functional outcome. Some studies have shown superior functional results and higher rates of healing following operative treatment. The aim of this study was to compare the outcome in these patients after nonoperative management with those treated with fixation. Patients and Methods In a multicentre, parallel randomized controlled trial, 146 adult patients with an acute displaced fracture of the midthird of the clavicle were randomized to either nonoperative treatment with a sling (71, 55 men and 16 women with a mean age of 39 years, 18 to 60) or fixation with a pre-contoured plate and locking screws (75, 64 men and 11 women with a mean age of 40 years, 18 to 60). Outcome was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) Score, the Constant Score, and radiographical evidence of union. Patients were followed for one year. Results A total of 60 patients in the nonoperative group and 64 in the operative group completed one-year follow-up. At three months’ follow-up, both the median DASH (1.7 vs 8.3) and median Constant scores (97 vs 90) were significantly better in the operated group (both p = 0.02). After six months and one year, there was no difference in the median DASH or Constant scores. The rate of nonunion was lower in the operative group (2 vs 11 patients, p < 0.02). Nine patients in the nonoperative group underwent surgery for nonunion. The plate was subsequently removed in 16 patients (25%). One patient had a new fracture after removal of the plate and one underwent revision surgery for failure of fixation. Conclusion Fixation of a displaced midshaft clavicular fracture using a pre-contoured plate and locking screws results in faster functional recovery and a higher rate of union compared with nonoperative management, but the function of the shoulder is equal after six months and at one year. Cite this article: Bone Joint J 2018;100-B:1385–91.