To document the incidence of late pain and hardware removal after open reduction and internal fixation (ORIF) of ankle fractures. To test the hypothesis that late pain overlying the distal tibial and fibular hardware is associated with poorer functional outcomes.

Retrospective review.

Level II trauma center.

One hundred twenty-six skeletally mature patients undergoing ORIF of unstable malleolar fractures who were followed up for at least six months from injury were included.

Analog pain score, Short Form-36 Health Survey (SF-36), and Short Form Musculoskeletal Functional Assessment (SMFA).

Thirty-nine (31 percent) of the 126 patients had lateral pain overlying their fracture hardware. Twenty-nine patients (23 percent) had had their hardware removed or desired to have it removed. Of the twenty-two patients with hardware-related pain who had undergone hardware removal, only eleven had improvement in their lateral ankle pain; the mean analog pain score decreased from 6 +/- 3.16 (mean +/- standard deviation) before hardware removal to 3 +/- 2.9 after hardware removal (p = 0.008). In general, SF-36 and SMFA scores at final follow-up were significantly lower for patients who had pain overlying their lateral hardware than for those who had no pain. For the group of patients who had lateral ankle pain, no significant difference was noted in SMFA or SF-36 scores for patients who had and who had not had their lateral hardware removed (p > 0.5).

The incidence of late pain overlying the distal tibial and fibular plate or screws is not insignificant. Although pain is generally decreased after hardware removal, nearly half of patients continue to have pain even after hardware removal. Functional outcome scores are poorer for patients with pain overlying lateral ankle hardware than in those with no pain at this location; this poorer outcome seems to be independent of whether the hardware was removed. Although the results of this study do not support or condemn the routine removal of fracture hardware after healing of unstable ankle fractures, they give orthopaedic surgeons some information that may assist them in counseling patients as to the expected functional outcome after ORIF of ankle fractures and the likelihood of relief of pain after removal of fracture hardware from the distal tibia and fibula.