Long term outcomes of a randomized control trial comparing fibular nail with open reduction and internal fixation in patients with unstable ankle fractures

N. Heinz, K. Bugler, N. Clement, X. Low, A. Duckworth, T. White

Background: Studies have compared open reduction internal fixation (ORIF) with fibular nail fixation (FNF) and shown reduced wound complications with minimal difference to PROMS in the short term. Our aim is to compare long-term outcomes for unstable ankle fractures at 10 year follow up.

Methods: Patients from a previously conducted RCT were contacted at a minimum of 10 years post intervention at a single study centre. Case notes were reviewed, and patient reported outcome measures acquired at 10 years.

Results: Ninety-nine patients were included (48 FNF and 51 ORIF). After 10 years 75% (33/44) of patients in the FNF group required no further follow up versus 81% (39/48) in the ORIF group. Radiographically at 2 years post-injury, there was no statistically significant difference between groups for development of osteoarthritis (p=0.851). There was one tibio-talar fusion in each group secondary to osteoarthritis, but no statistically significant difference in overall reoperation rate (p=0.518). Fifty-one percent (n=50) of patients have so far returned patient reported outcome measures at a minimum of 10 years (Fibular nail n=23, plate fixation n=27). No significant difference was found between groups for the mean scores of Olerud and Molander Ankle Score (FNF 84.78 vs ORIF 84.07; p=0.883), the Manchester-Oxford Foot Questionnaire (MOXFQ) (FNF 89.54 vs ORIF 96.47; p=0.112), Euroqol-5D Index (FNF 0.88 vs ORIF 0.87; p=0.701) and Euroqol-5D Visual Analogue Score (FNF 77.30 vs ORIF 77.52; p=0.859).

Conclusion: The current study illustrates that both methods of treatment result in a satisfactory long-term outcome with no difference in late complications or PROM scores at up to 10 years in patients under 65 years old, although the study is currently under powered.