A prospective, randomised, controlled, two-centre, international trial comparing the fibular nail with open reduction and internal fixation for unstable ankle fractures in younger patients.

OBJECTIVE To compare the outcome of fibular nailing with plate fixation for unstable fractures of the ankle in a cohort of patients under the age of 65. SETTING two international university trauma centres,Patients/Participants 125 patients 18-64 years of age with an acute unstable fracture of the ankle. INTERVENTION Patients were randomized to fixation with a fibular nail (n=63) or plate (n=62) and were reviewed at 6 weeks, 3 months, 6 months, 1-year and 2-years following surgery. MAIN OUTCOME MEASUREMENTS The primary outcome measure was the Olerud and Molander score (OMS) at one-year. Secondary outcomes were the rates of complications and re-interventions. RESULTS There was no difference between the two groups with respect to the primary outcome measure (mean OMS 78.4 in the nail group vs. 80.2 in the plate group (p=0.621)). Wound infections occurred in two patients who were treated with a nail, and nine patients who were treated with a plate, but this did not reach statistical significance. No difference was seen in the overall rate of complicatons and re-interventions between groups (28.6% in the nail group vs. 29% in the plate group (p=0.955)). CONCLUSIONS In younger patients with ankle fractures, no difference was found in the patient reported outcome between fibular nail and plate fixation at one-year following surgery. The fibular nail is an effective and safe option for the stabilisation of ankle fractures in younger patients, although the benefits associated with reduced wound complications are not as apparent as for elderly patients. LEVEL OF EVIDENCE Therapeutic Level 1. See Instructions for Authors for a complete description of levels of evidence.