Comparative study of non operative management with primary anatomical locking plating of middle third displaced clavicle fractures - randomised clinical trial

Abstract

Background: Current studies have proven increased prevalence of symptomatic non unions and mal union after non operative management of displaced fractures of mid shaft clavicle. We need to compare outcome and complications between non operative management and primary anatomical locking plating of displaced middle third clavicular fractures. Methods: In a prospective clinical trial 110 patients with middle third displaced clavicle fractures were randomized to either treatment with primary anatomical locking plate fixation (63) [group 1] or non operative management with sling (47) [group 2]. Outcome was based on standard clinical follow up, constant shoulder score, Disability of the Arm, Shoulder, and Hand (DASH) score and plain radiographs. 85 patients completed 1year of follow up.Between the groups with relation to demography, mechanism of injury, associated injuries, injury severity score, fracture pattern, there were no difference. Results: In group 1, there was a significant improvement in constant shoulder score and DASH score at all time-points. (p=0.001 and p<0.01 respectively). Mean duration for union was 16.0 weeks in 1st group and 28.0 weeks in group 2. There were 2 non unions in the group 1 compared with six in the group 2. Symptomatic malunion developed in 8 patients in the group 2 and nil in the group 1. Almost complications in the group 1 were hardware-related (patients had irritation, prominent hardware, wound infection, and mechanical failure). At twelve months of the injury, the patients in the group 1 were satisfied with appearance of the shoulder and in general than were those in group 2. Conclusion: fixation of a displaced clavicle fractures of middle third shaft with anatomical locking plate results in good functional outcome and a lower rate of complications on comparing with nonoperative treatment at 12 months of follow-up. Hardware elimination remains the most customary reason for second surgery in the group 1. This study supports primary fixation with precontoured locking plate of well displaced middle third fractures of clavicle in active young patients.