Safety of a novel high tibial osteotomy locked plate fixation for immediate full weight-bearing: A case-control study

摘要

Purpose: The safety and efficacy of the novel Limmed? system (locked plate fixation) for immediate full weight-bearing after medial opening wedge high tibial osteotomy (HTO) were evaluated in patients with symptomatic varus gonarthrosis. Methods: A case series of 85 consecutive osteotomies performed with Limmed? locked plate fixation for medial opening wedge HTO was compared to a historical matched case-control series of 85 HTOs (85 patients) performed using the same implant without locked screws. Subjects were observed at seven and 15 days and three, six and 12 months after surgery. Endpoints for evaluation included the reporting of adverse events, weight-bearing status without pain, radiographic evidence of bony union and changes in correction angle during healing. Results: Statistically significant differences were seen between groups in terms of safety (thrombophlebitis), time to weight-bearing, radiographic union and radiographic stability between the two groups. Patients of the Limmed? group reported less thrombophlebitis (one versus nine), outcome with shorter time for full weight-bearing (average 45 days difference, p = 0.01) and a shorter time for union (average four weeks difference). At the one-year follow-up the post-operative hip-knee-ankle angle was 4.2 of valgus in the Limmed? group and 2 of valgus in the control group. The adjusted mean difference of 2.2 was significant (p = 0.02) and related to loss of correction during healing in the control group with difference in implant stability. The severity of pain, knee score and walking ability improved in both groups with a significant difference before the third month (quicker for Limmed? group), while at the most recent follow-up only the difference for mobility in flexion was significant. Conclusions: The Limmed? medial opening wedge HTO system represents a novel method of achieving a reliable correction while producing a stable fixation allowing satisfactory stability and bone healing with immediate full weight-bearing.