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ALENDRONATE IMPROVES FIXATION IN OSTEOPOROTIC BONE. A PROSPECTIVE RANDOMIZED CLINICAL STUDY OF PERTROCHANTERIC FRACTURES



Abstract

Introduction: Screw loosening is a common complication of osteoporotic fracture fixation leading to implant loosening, fracture malunion and non-union. Because recent animal studies have shown that bisphosphonates improve implant fixation we wanted to assess whether alendronate (ALN) improves screw fixation in a clinical setting of osteoporotic fractures.

Methods: Sixteen consecutive patients with AO/OTA A1 pertrochanteric fractures were selected. Inclusion criteria were: female over the age of 65, BMD T-score less than −2.5 SD. Fractures were fixed with a pertrochanteric fixator and 4 hydroxyapatite (HA)-coated screws. Two screws were implanted in the femoral head (screw positions 1 and 2) and two in the femoral diaphysis (screw positions 3 and 4). Patients were randomized to either postoperative systemic administration of ALN, 70 mg per week for 3 months (Group A) or no ALN. Fixators were removed at 3 months post-op in all patients.

Results: All the fractures healed. No differences in screw insertion torque between the two groups were found. No pin loosening or infection occurred. The combined mean extraction torque of the screws implanted at positions 1 and 2 (cancellous bone) was 3181 ± 1385 N/mm in Group A and 1890 ± 813 N/mm in Group B (p < 0.001). The combined mean extraction torque of the screws implanted at positions 3 and 4 (cortical bone) was 4327 ± 1720 N/mm in Group A and 3785 ± 1181 N/mm in Group B (ns).

Discussion and Conclusion: This is the first study to demonstrate in a clinical setting improved screw fixation following post-operative ALN treatment. We observed a two-fold fixation increase in the screws implanted in cancellous bone. With cortical bone, the difference in screw fixation was less marked. Besides its bone preserving ALN should be recommended as an effective solution to improve fixation in osteoporotic bone.

Correspondence should be addressed to Ms Larissa Welti, Scientific Secretary, EFORT Central Office, Technoparkstrasse 1, CH-8005 Zürich, Switzerland