Medial Malleoli Fractures: Clinical Comparison Between Newly Designed Sled Device and Conventional Screws.

BACKGROUND: The Trimed Medial Malleolar Sled is a newer device designed to treat medial malleolus fracture. The purpose of this study was to compare the outcome of medial malleolar fractures treated with the sled and conventional malleolar screws.

METHODS: After obtaining an institutional review board approval, we conducted a retrospective study to identify all skeletally mature patients who sustained an ankle fracture with medial malleolar involvement treated with the sled and we identified a matched cohort treated with conventional malleolar screws. The patients were divided into 2 groups: group A included patients treated with malleolar screws and group B included patients treated with the sled device. The outcomes measured included rate of union, implant removal, and pain over the implant site.

RESULTS: Eighty-five medial malleolar ankle fractures were divided into 2 groups: group A included patients (n = 64) treated with malleolar screws and group B included patients (n = 21) treated with the sled device. In group A (n = 64), 62 patients (96.8%) achieved radiological union with a mean union rate of 11 weeks and 10 (15%) patients underwent repeat surgery for implant removal of which 3 patients (4.6%) had pain specifically over the medial implant. In group B (n = 21), all of the patients (100%) achieved radiological union with a mean union rate of 10.8 weeks and 3 patients (14.2%) underwent repeat surgery of which 1 (4.7%) was related to the medial pain. There is no significant difference between the groups for the outcomes measured, including rate of union (  P = .93), visual analog scale score for pain (  P = .07), implant removal (  P = .41), and pain over the implant site (  P = .88).

CONCLUSION: Based on the data from our study, we conclude that there are no major differences between the sled devices and conventional screws relating to union rate and complications.

LEVELS OF EVIDENCE: Level III: Observational study.