Results of a Prospective Randomized Study Following Osteosynthesis Using 1/3 Tubular Plate in AO Technique vs Osteosynthesis Using Polyaxial Locking Plates in Distal Fibula Fracture

Abstract

Category: Ankle, Trauma Introduction/Purpose: In modern economies health care comprising treatment and disability after trauma is a financial burden. In this context techniques of ORIF that allow for early full weight bearing might not only improve the clinical outcome but also shorten the period of working disability. The aim of the study is to analyze whether ORIF of ankle fractures using a new polyaxial locking or a standard tubular plate allow for a better outcome and reduction of complications. Methods: In this prospective study, all patients with a distal fibula fracture (AO 44 B1.1, B1.2, B1.3), who met the criteria for surgical treatment were included. Patients were randomized to either the group A (tubular plate, Depuy Synthes) or group B (polyaxial locking plate, NEWCLIP TECHNICS, Active Ankle®). First outcome parameter was functionality of the ankle joint, assessed by the Olerud and FAOS score. Secondary outcome parameter were postoperative complications. These were divided into minor complications: Superficial wound infection, delayed wound healing, mechanically prominent implant, skin irritations and major complications requiring surgical revision: Deep wound infection, material loosening, loss of reduction. Clinical and radiological controls were performed 6 weeks, 12 weeks, 6 months and 1 year postoperatively. Results: 52 patients (31W/21 M) with an age of 43y (range 22-64) have been included. 7 Patients (13.5%) dropped out. 45 patients were available for follow up. 20 patients were treated with polyaxial locking plates (44.4%), 25 patients by 1/3 tubular plate in AO technique (55.6%). Two minor complications (16%) occurred in the Active Ankle® group, four minor complications (16%) in the AO arm. At the first two control stages after six and 12 weeks a significant distinctions in the Olerud and FAOS score could be obtained in between the two study arms. Mean Olerud score after 6 weeks AA 56,05/AO 45,22 p=0,02, after 12 weeks AA 69,47/AO 59,79 p=0,04. Mean FAOS in week 6 AA 66,7/AO 56,08 p=0,02, in week 12 AA 75,1/AO 66,12 p=0,03. Conclusion: Our results are quite positive. We could demonstrate that a significant better clinical function during the early postoperative stages, after 6 weeks and 12 weeks, presented in the group treated with polyaxial locking plates. Further we proved that ORIF with polyaxial locking plates is a safe and stabile osteosyntheses and could promote an early weight bearing postoperative regime. That has the consequence that we could shorten the absence from work, the patient’s mobility can be restored faster and the costs for the health care system decrease significantly.