Study Design. Laboratory analysis of explanted MAGnetic Expansion Control (MAGEC) rods. Objective. The aim of this study was to identify the in vivo lengthening of MAGEC rods. Summary of Background Data. Little data is available regarding the lengthening achieved by MAGEC rods. Methods. Cases were identified from the largest series of independently analyzed explanted MAGEC rods. The in vivo growth of rods was determined by the distance between the first “growth mark” and the actuator. The instrumented spinal lengthening was calculated for each construct. Constructs were considered functional if all rods could lengthen with external remote controller activation and no rods were “telescoping”. Results. Fifty-five MAGEC constructs (99 rods) from 53 patients treated at 10 centers were included. The mean age at insertion was 8.5 years with rods implanted a mean of 35 months. Sixty rods were suitable for analysis with mean lengthening 21.7 mm, 8.9 mm/year. Of these 60 rods, three were maximally distracted. Mean instrumented spinal lengthening for 38 suitable cases was 22.1 mm, 8.4 mm/year. This was positively correlated with the duration of implantation (r = 0.34, P = 0.04) but negatively with patient age at insertion (r = −0.35, P = 0.03). The rate of instrumented spinal lengthening was negatively correlated with duration of implantation (r = −0.47, P = 0.004). Of 55 constructs, 34 were nonfunctional at time of removal with nine functional and 12 indeterminate. Functional constructs had been implanted significantly less time (20.0 vs. 39.7 months, P < 0.001) and lengthened less than those nonfunctional (12.3 mm vs. 23.3 mm, P = 0.04). Conclusion. This multicenter explant study represents the largest cohort managed with MAGEC rods reported. Rods are very rarely removed having fully lengthened with mean instrumented spinal growth of 22 mm over the implant's life. This may be explained by a high rate of lengthening mechanism failure in received rods after around 3 years in vivo. Our findings question the effectiveness of the MAGEC system and mandate urgent comparative clinical studies. Level of Evidence: 4
Generation of wear debris and wear particle-induced osteolysis are the main limitations of metal-on-polyethylene artificial joints. Cross-linked polyethylene has been recently used, particularly in hip replacements, as an alternative material to conventional ultrahigh molecular weight polyethylene due to its superior wear resistance. This study focused on the wear behaviour of cross-linked polyethylene under different contact stresses in order to make interpretations of its long-term in-vivo performance. A 50-station SuperCTPOD (pin-on-disc) machine was used to investigate the influence of contact stress on the wear of cross-linked polyethylene pins which were articulated against cobalt chromium discs. It was found that the wear rate of cross-linked polyethylene was lower at higher contact stresses.
Study Design. Analysis of explanted MAGnetic Expansion Control (MAGEC) growing rods. Objective. The aim of this study was to quantify the rate of locking pin breakage in explanted MAGEC rods and compare with the manufacturer's data. Summary of Background Data. On June 25, 2019, NuVasive released an Urgent Field Safety Notice stating that MAGEC rods manufactured before March 26, 2015 had a higher than expected locking pin breakage rate of 5%. For rods made on or after that date, no pin breakages had occurred. Methods. From our independent explant database of 139 explanted MAGEC rods supplied from 10 UK spinal centers (Belfast, Bristol, Birmingham, Edinburgh, Exeter, Leeds, Newcastle, Nottingham, Oxford, and Sheffield) and one Danish center (Aarhus), we divided the rods into those manufactured before March 26, 2015, and those manufactured on or after that date. MAGEC rods were cut open to fully assess internal components including locking pins. From each of the two cohorts, 10 locking pins were selected at random and their diameters were measured using a micrometer. Results. One hundred and five explanted MAGEC rods were made before March 26, 2015 and could be disassembled to allow the locking pin to be examined. Fifty-nine percent (62/105) of these locking pins had fractured. For the MAGEC rods manufactured on or after March 26, 2015, 21% (6/29) were found to have fractured locking pins. Locking pins in MAGEC rods made on or after March 26, 2015 were of a stronger material and a larger diameter. Conclusion. Fifty-nine percent of the locking pins in MAGEC rods manufactured before March 26, 2015 had fractured, far greater than the 5% stated in the Urgent Field Safety Notice. Locking pin fracture still occurred in MAGEC rods manufactured on or after that date, in 21% of cases. This contrasted with the 0% reported by the manufacturer. Level of Evidence: 4
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