Implants used to correct pathological varus-valgus deformities (VVD) and leg length discrepancies (LLD) may not be optimized for the specific treatment, as suggested by their off-label use. Detailed analysis of this issue has been limited by the poorly understood mechanical behavior of the growing physis and ignorance of the loads acting on the implants. The aim of this study was to predict and compare the loading conditions of a growth modulation implant in VVD and LLD treatments. Idealized finite element (FE) models of the juvenile distal femur treated with the Eight-Plate implant were developed for VVD and LLD. Bone growth was simulated using thermal strains. The axial force in the plate was compared between the two treatments. Case-specific plate forces were predicted by virtually reproducing the screw deformation visible on radiographs of LLD (N = 4) and VVD (N = 4) clinical cases. The simple FE models reproduced the clinical implant deformations well. The resulting forces ranged from 129 to 580 N for the VVD patients. For LLD, this range was from 295 to 1002 N per plate, that is, 590-2004 N for the entire physis. The higher forces in LLD could be explained by restricted screw divergence in the double-sided implant application. For the first time, the loading conditions of a growth modulation implant were investigated and compared between two treatments by FE analyses, and the range of case-specific loads was predicted. These simulation tools may be utilized for guiding appropriate usage and for efficient development of implants. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:1398-1405, 2018.
Purpose Varus-valgus deformities in children and adolescents are often corrected by temporary hemi-epiphysiodesis, in which the physis is bridged by an implant to inhibit growth. With standard implant solutions, the acting forces cannot be regulated, rendering the correction difficult to control. Furthermore, the implant load steadily increases with ongoing growth potentially leading to implant-related failures. A novel implant concept was developed applying a controlled constant force to the physis, which carries the potential to avoid these complications. The study aim was to proof the concept in vivo by analyzing the effect of three distinct force levels on the creation of varus deformities. Methods The proposed implant is made of a conventional cerclage wire and features a twisted coil that unwinds with growth resulting in an implant-specific constant force level. The proximal medial tibial physes of 18 lambs were treated with the implant and assigned to three groups distinct by the force level of the implant (200 N, 120 N, 60 N). Results The treatment appeared safe without implant-related failures. Deformity creation was statistically different between the groups and yielded on average 10.6° (200 N), 4.8° (120 N) and 0.4° (60 N) over the treatment period. Modulation rates were 0.51°/mm (200 N), 0.23°/mm (120 N) and 0.05°/mm (60 N) and were constant throughout the treatment. Conclusion By means of the constant force concept, controlled growth modulation appeared feasible in this preclinical experiment. However, clinical trials are necessary to confirm whether the results are translatable to the human pathological situation.
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