Introduction: Sufficiently stable constructs may be difficult to obtain with ankle fractures in patients with severe osteopenic bone. Augmentation of the osteosynthesis with a new synthetic bone void filler may help to solve this problem, and it can improve the clinical outcome.
Materials and methods: A prospective, open-label study was performed in two surgical clinics in Norway. In 37 of 42 selected patients with Weber type B ankle fractures showing clinical and radiologic signs of osteopenic bone, at least one screw was found to be stripping during open reduction and internal fixation (ORIF). All the stripped screws were augmented with the bone void filler, and tightness was assessed clinically afterwards. All patients were followed up for 2 years. Successful healing of the fracture after 3 months and absence of radiographic movement of the augmented screws were assessed relative to the plate and the bone. Safety was assessed by recording adverse events and abnormal haematology findings.
Results: All 86 augmented screws were clinically tight after augmentation. After 3 months, all fractures healed, and 1 augmented and 1 non-augmented screw appeared to be radiographically loose. After 2 and 6 months, respectively, deep wound infections occurred in 2 patients (5%), necessitating antibiotic treatment, revision surgery and implant removal. After 2 years, all patients had resumed their normal daily activities, and none of the augmented screws showed signs of loosening.
Conclusions: Augmentation of bone screws with this new synthetic bone void filler was an effective means of gaining screw anchorage. Screw stabilisation with the new synthetic bone void filler proved to be safe and effective in the ORIF of ankle fractures in patients with osteopenic bone.