This multi-centre single-blind randomised control trial compared outcomes in patients with acute displaced mid-shaft clavicle fractures treated either by primary open reduction and plate fixation (ORPF), or non-operative treatment (NT). Two-hundred patients were randomised to receive either ORPF or NT. Functional assessment was conducted up to one-year using DASH, SF-12 and Constant scores (CS). Union was evaluated using radiographs and CT. Rate of non-union was significantly reduced after ORPF (1 following ORPF, 16 following NT, odds ratio=0.07, 95% CI=0.01–0.50, p=0.0006). 7 patients had delayed-union after NT. Group allocation to ORPF was independently predictive of development of non-union. DASH and CS were significantly better in the ORPF group 3-months post-surgery, but not at one-year (mean DASH = 6.2 after NT versus 3.7 after ORPF, p=0.09; mean CS = 86.1 after NT versus 90.7 after ORPF, p=0.05). Group allocation was not predictive of one-year outcome. Non-union was the only factor independently predictive of one-year functional outcome. There were no significant differences in time off work or subjective scores. Five patients underwent revision for complications after ORPF. 10 patients underwent metalwork removal. Treatment cost was significantly greater after ORPF (p=0.001). ORPF reduces rate of non-union compared with NT and is associated with better early functional outcomes. Improved outcomes are not sustained at one-year. Differences in functional outcome appear to be mediated by prevention of non-union from ORPF. ORPF is more expensive and associated with implant-related complications not seen with NT. Our results do not support routine primary ORPF for displaced mid-shaft clavicle fractures.
Non-union has traditionally been considered a rare complication following the non-operative management of clavicle fractures. A growing body of evidence has demonstrated higher rates of non-union in adults with displaced fractures. However, the variables that predict non-union in these patients remain unclear. We evaluated the prevalence and risk factors for non-union following displaced midshaft clavicle fractures in a large consecutive series of patients managed non-operatively in our Unit. 1097 consecutive adults (mean age 26.1yrs) with displaced midshaft clavicle fractures treated non-operatively in our Unit were included. All patients were interviewed and examined by an orthopaedic trauma surgeon and underwent radiological assessment within a week of injury. All patients were managed in a simple sling for two weeks followed by early mobilization. All patients were followed-up until clinical and radiological confirmation of union. Non-union was defined clinically as the presence of pain or mobility of the fracture segments on stressing, and radiologically as failure of cortical bridging by 6 months.Background
Materials and Methods
Non-union has traditionally been considered a rare complication following the non-operative management of clavicle fractures. Recent studies demonstrate higher rates of non-union in adults with displaced fractures, yet the variables predicting non-union remain unclear. We evaluated the prevalence and risk factors for non-union following displaced midshaft clavicle fractures in a large consecutive series of patients managed non-operatively. 1097 consecutive adults (mean age 26.1yrs) with displaced midshaft clavicle fractures treated non-operatively in our Unit were included. All patients were interviewed, examined and underwent radiological assessment within a week of injury. All patients were managed in a sling for two weeks followed by early mobilization. All patients were followed-up until clinical and radiological confirmation of union. Non-union was defined clinically as pain or mobility of the fracture segments on stressing, and radiologically as failure of cortical bridging by 6 months. 198 (18%) of patients had evidence of non-union at 6 months. Patient factors associated with non-union included increasing age, smoking and the presence of medical comorbidities (p<0.05). Injury-related factors associated with non-union included increasing fragment translation and displacement, and injury pattern (Edinburgh 2B2: comminuted segmental fracture)(p<0.01). We present the largest series reporting prevalence and risk factors for non-union following conservatively treated, displaced midshaft clavicle fractures. These fractures can no longer be viewed as a single clinical entity, but as a spectrum of injuries each requiring individualized assessment and treatment. Increased understanding of the outcomes of these injuries will enable clinicians to better identify those patients that may be better served with primary operative reconstruction.
