Single-Screw Fixation Compared With Double Screw Fixation for Treatment of Medial Malleolar Fractures: A Prospective Randomized Trial

Objectives: To determine whether single or double screw (DS) fixation of medial malleolar fractures results in better long-term health outcomes. Design: Randomized clinical trial; sealed envelope technique. Setting: Level 1 Trauma Hospital at University of Calgary, Canada. Patients: One hundred forty patients were randomized to receive either 1 or 2 screws to reduce a medial malleolar fracture. Thirteen patients were excluded because of loss to follow-up (n = 127). Intervention: Surgical fixation of the medial malleolar fracture was performed using 1 or 2 stainless steel screws. Main Outcome Measurements: Primary outcome was comparison of physical functioning summary score on Short Form 36 questionnaires between patients in the 2 groups. Secondary objectives were to compare the Ankle Hindfoot Scale and operating room time. Clinical and radiographic assessment occurred at the time of injury and 2, 6 weeks, 3, 6, 12, and 24 months postoperatively. Results: Fourteen patients crossed over from the DS group to the single screw (SS) group based on intraoperative decisions by the surgeon (fragment too small for 2 screws), leaving the SS (n = 75) and DS groups (n = 52). There was no difference in the operating room time, SF36, or Ankle Hindfoot Scale at all follow-up time points. Conclusions: SS medial malleolar fixation provides an equally safe and effective method of fracture care as compared to DS fixation. Twenty percent of patients receiving 2 screws can be expected to crossover to receive SS fixation as a safer alternative.