Pin Fracture in Magnetically Controlled Growing Rods: Influence of the Year of Manufacture.

BACKGROUND: Magnetically controlled growing rods (MCGRs) have a known issue with fracture of the internal locking pin resulting in early revisions. The manufacturer reported that rods manufactured before March 26, 2015, had a 5% risk of locking pin fracture. Locking pins made after this date are thicker in diameter and of a tougher alloy; their rate of pin fracture is not known. The aim of this study was to better understand the impact of the design changes on the performance of MCGRs. METHODS: This study involves 46 patients with 76 removed MCGRs. Forty-six rods were manufactured before March 26, 2015, and 30 rods after that date. Clinical and implant data were collected for all MCGRs. Retrieval analysis comprised plain radiographs evaluations, force and elongation testing, and disassembly. RESULTS: The 2 patient groups were statistically comparable. We found that 14 of 27 patients implanted with rods manufactured before March 26, 2015 (group I) had a fracture of their locking pins. Three of the 17 patients with rods manufactured after this date (group II) were also found to have a fractured pin. CONCLUSIONS: Retrieved rods collected at our center and made after March 26, 2015, had far fewer locking pin fractures than those made before this date; this may be due to the change in pin design.

Understanding the implant performance of magnetically controlled growing spine rods: a review article.

PURPOSE: Early-Onset Scoliosis (EOS) (defined as a curvature of the spine ≥ 10° with onset before 10 years of age) if not properly treated, can lead to increased morbidity and mortality. Traditionally Growing Rods (TGRs), implants fixated to the spine and extended every 6-8 months by surgery, are considered the gold standard, but Magnetically Controlled Growing Rods (MCGRs) avoid multiple surgeries. While the potential benefit of outpatient distraction procedure with MCGR is huge, concerns still remain about its risks, up to the release of a Medical Device Alert (MDA) by the Medicines and Healthcare Regulatory Agency (MHRA) advising not to implant MCGRs until further notice. The aim of this literature review is to (1) give an overview on the use of MCGRs and (2) identify what is currently understood about the surgical, implant and patient factors associated with the use of MCGRs. METHODS: Systematic literature review. RESULTS: Surgical factors such as use of single rod configuration or incorrect rod contouring might affect early failure of MCGRs. Patient's older age and higher BMI are correlated with rod slippage. Wear debris and distraction mechanism failure may result from implant design and iteration. CONCLUSION: Despite the complications reported, this technology still offers one of the best solutions to spine surgeons dealing with severe EOS. Lowering the complication rate by identifying risk factors for failure is possible and further studies in this direction are required. Once the risk factors are well described, some of these can be addressed enabling a safer use of MCGRs.

Reconstruction of acetabular defects greater than Paprosky type 3B: the importance of functional imaging.

BACKGROUND: 3D Surgical planning has become a key tool in complex hip revision surgery. The restoration of centre of rotation (CoR) of the hips and leg length (LL) are key factors in achieving good clinical outcome. Pelvic imaging is the gold standard for planning and assessment of LL. We aimed to better understand if 3D planning is effective at equalising LL when large acetabular defects are present. MATERIALS AND METHODS: This was a prospective case study of 25 patients. We report the analysis of pre-operative LL status and planned LL restoration measured on CT, in relation to the achieved LL measured post-operatively in functional, weight bearing position. Our primary objective was the assessment of restoration of CoR as well as the anatomical and functional LL using biplanar full-length standing low-dose radiographs; our secondary objective was to evaluate the clinical outcome. RESULTS: Pre-operative intra-pelvic discrepancy between right and left leg was a mean of 28 mm (SD 17.99, min = 3, max = 60 mm). Post-operatively, the difference between right and left vertical femoral offset (VFO), or CoR discrepancy, was of 7.4 mm on average, significantly different from the functional LL discrepancy (median = 15 mm), p = 0.0024. Anatomical LLD was a median of 15 mm. In one case there was transient foot drop, one dislocation occurred 6 months post-operatively and was treated by closed reduction, none of the patients had had revision surgery at the time of writing. Mean oxford hip score at latest follow up was 32.1/48. DISCUSSION: This is the first study to investigate limb length discrepancy in functional position after reconstruction of large acetabular defects. We observed that VFO is not an optimal surrogate for LL when there is significant bone loss leading to length inequality, fixed flexion of the knee and abduction deformity. CONCLUSIONS: Although challenging, LLD and gait abnormalities can be greatly improved with the aid of an accurate surgical planning. Surgeons and engineers should consider the integration of EOS imaging in surgical planning of reconstruction of large acetabular defects.

Management of patients with magnetically controlled growth rods amidst the global COVID-19 pandemic.

INTRODUCTION: At the time of writing, we are all coping with the global COVID-19 pandemic. Amongst other things, this has had a significant impact on postponing virtually all routine clinic visits and elective surgeries. Concurrently, the Magnetic Expansion Control (MAGEC) rod has been issued with a number of field safety notices and UK regulator medical device alerts. METHODS: This document serves to provide an overview of the current situation regarding the use of MAGEC rods, primarily in the UK, and the impact that the pandemic has had on the management of patients with these rods. RESULTS AND CONCLUSION: The care of each patient must of course be determined on an individual basis; however, the experience of the authors is that a short delay in scheduled distractions and clinic visits will not adversely impact patient treatment. The authors caution against a gap in distractions of longer than 6 months and emphasise the importance of continued remote patient monitoring to identify those who may need to be seen more urgently.

Mechanical wear analysis helps understand a mechanism of failure in retrieved magnetically controlled growing rods: a retrieval study.

BACKGROUND: To assess the relationship between mechanical wear and the failure of the internal lengthening mechanism in retrieved MAGnetic Expansion Control (MAGEC) growing rods. METHODS: This study included 34 MAGEC rods retrieved from 20 patients. The state of the internal mechanism and mechanical wear were assessed in all the rods using plain radiographs and visual inspection. Metrology was then performed to assess the topography and mechanical wear of the telescopic bars, using a Talyrond 365 (Taylor Hobson, Leicester, UK) roundness measuring machine. RESULTS: Plain radiographs showed evidence of a broken internal mechanism in 29% of retrieved rods. Single-side wear marks were found in 97% of retrieved rods. Material loss was found to significantly increase in rods with a damaged internal mechanism (p < 0.05) and rods with longer time in situ (r = 0.692, p < 0.05). CONCLUSIONS: We found an association between damage to the internal mechanism of the rods and (1) patterns of single-side longitudinal wear marks and (2) increased material loss. As the material loss was also found to increase over time of rod in situ, we emphasise the importance of early detection and revision of failed MAGEC rods in clinical practice.