Growing rods in Early Onset Scoliosis: The current scenario.

Background and aims: The treatment of early onset scoliosis is a challenge. Some curves resolve spontaneously, while the more aggressive ones require surgical intervention. Several surgical strategies have been explored in this unique group of patients, though the distraction based growing rods are the mainstay of treatment. The aim of this paper is to consider the current scenario with the surgical treatment for early onset scoliosis with growing rods. Methods: This is a narrative review that explores the various types of growing rod options that are currently available. The results, as reported in literature, are discussed. The complications and problems with the commonly used growing rods are explored, based on the reported literature and on retrieval analysis that we have published. We discuss some of the newer modifications of growing rods. Results: There is no real consensus on the ideal timing for the surgery or ways to assess the outcomes of the treatment. The Cobb angle measurement and measures of thoracic growth are surrogate markers. The main indication for surgery is to an increase in the thoracic dimensions and allowing for lung growth. Measures that are linked to lung function are more useful. We report some newer MRI scanning technology. Distraction-based growing rods have been reported to produce consistent and good results. Frequent return to theatre with the Traditional Growing Rods (TGR) and the metallosis related problems with the MCGR are reported. Conclusions: We have learned a lot from the TGR and MCGR experiences. There is a scope for ongoing research to improve the design of the implant systems and better assess the outcomes on lung function. This review outlines these and helps identify the future trends.

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.

Rod Fracture in Magnetically Controlled Growing Spine Rods.

BACKGROUND: The mechanisms of fracture in magnetically controlled growing rods (MCGRs) and the risk factors associated with this are poorly understood. This retrospective analysis of explanted MCGRs aimed to add understanding to this subject. METHODS: From our cohort of over 120 retrieved MCGRs, we identified 7 rods that had fractured; all were single-rod constructs, retrieved from 6 patients. These were examined and compared with 15 intact single-rod constructs. Retrieval and fractographic analyses were used to determine the failure mode at the fracture site and the implant's functionality. Cobb angle, degree of rod contouring, and the distance between anchoring points were computed on anteroposterior and lateral radiographs. RESULTS: 5/7 versus 3/15 rods had been inserted after the removal of a previously inserted rod, in the fractured versus control groups. All fractured rods failed due to bending fatigue. Fractured rods had greater rod contouring angles in the frontal plane ( P = 0.0407) and lateral plane ( P = 0.0306), and greater distances between anchoring points in both anteroposterior and lateral planes ( P = 0.0061 and P = 0.0074, respectively). CONCLUSIONS: We found all failed due to a fatigue fracture and were virtually all single rod configurations. Fracture initiation points corresponded with mechanical indentation marks induced by the intraoperative rod contouring tool. Fractured rods had undergone greater rod contouring and had greater distances between anchoring points, suggesting that it is preferable to implant double rod constructs in patients with sufficient spinal maturity to avoid this complication. CLINICAL RELEVANCE: Level III.

Blood titanium levels in patients with large and sliding titanium implants.

BACKGROUND: Titanium, which is known to be a highly biologically inert element, is one of the most commonly used metals in orthopaedic implants. While cobalt and chromium blood metal ion testing is routinely used in the clinical monitoring of patients with metal-on-metal hip implants, much less is known about the levels of titanium in patients with other implant types. The aim of this study was to better understand the normal ranges of blood titanium levels in patients implanted with large and sliding titanium constructs by comparison with reference levels from conventional titanium hips. METHODS: This study examined data collected from 136 patients. Over a period of 24 months, whole blood samples were collected from 41 patients implanted with large titanium implants: long (range 15 to 30 cm) spine rods with a sliding mechanism ("spine rods", n = 18), long bone tumour implants ("tumour implants", n = 13) and 3D-printed customised massive acetabular defect implants ("massive acetabular implants", n = 10). This data was compared with standard, uncemented primary titanium hip implants ("standard hips", 15 cm long) (n = 95). Clinical, imaging and blood titanium levels data were collected for all patients and compared statistically between the different groups. RESULTS: The median (range) of blood titanium levels of the standard hip, spine rods, femoral tumour implants and massive acetabular implants were 1.2 ppb (0.6-4.9), 9.7 ppb (4.0-25.4), 2.6 ppb (0.4-104.4) and 5.7 ppb (1.6-31.5) respectively. Spine rods and massive acetabular implants had significantly greater blood titanium levels compared to the standard hips group (p < 0.001). CONCLUSION: This study showed that titanium orthopaedic implants that are large and/or have a sliding mechanism have higher blood titanium levels compared to well-functioning, conventionally sized titanium hips. Reassuringly, the increased levels did not appear to induce adverse metal reactions. This study provides useful baseline data for future studies aimed at assessing blood titanium levels as a biomarker for implant function.

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.

Why are tapes better than wires in knotless rotator cuff repairs? An evaluation of force, pressure and contact area in a tendon bone unit mechanical model.

PURPOSE: Knotless repairs have demonstrated encouraging performance regarding retear rate reduction, but literature aiming at identifying the specific variables responsible for these results is scarce and conflictive. The purpose of this paper was to evaluate the effect of the material (tape or wire suture) and medial tendon passage (single or double passage) on the contact force, pressure and area at the tendon bone interface in order to identify the key factors responsible for this repairs´ success. METHODS: A specific knotless transosseous equivalent cuff repair was simulated using 2 tape or suture wire loaded medial anchors and 2 lateral anchors, with controlled lateral suture limb tension. The repair was performed in a previously validated sawbones® mechanical model. Testing analyzed force, pressure and area in a predetermined and constant size "repair box" using a Tekscan® sensor, as well as peak force and pressure, force applied by specific sutures and force variation along the repair box. RESULTS: Tapes generate lower contact force and pressure and double medial passage at the medial tendon is associated with higher contact area. Suture wires generate higher peak force and pressure on the repair and higher mean force in their tendon path and at the medial bearing row. Force values decrease from medial to lateral and from posterior to anterior independently of the material or medial passage. CONCLUSION: Contrary to most biomechanical literature, suture tape use lowers the pressure and force applied at the tendon bone junction, while higher number of suture passage points medially increases the area of contact. These findings may explain the superior clinical results obtained with the use uf suture tapes because its smaller compressive effect over the tendon may create a better perfusion environment healing while maintaining adequate biomechanical stability.

Subject-specific FE models of the human femur predict fracture path and bone strength under single-leg-stance loading.

Hip fractures are a major health problem with high socio-economic costs. Subject-specific finite element (FE) models have been suggested to improve the fracture risk assessment, as compared to clinical tools based on areal bone mineral density, by adding an estimate of bone strength. Typically, such FE models are limited to estimate bone strength and possibly the fracture onset, but do not model the fracture process itself. The aim of this study was to use a discrete damage approach to simulate the full fracture process in subject-specific femur models under stance loading conditions. A framework based on the partition of unity finite element method (PUFEM), also known as XFEM, was used. An existing PUFEM framework previously used on a homogeneous generic femur model was extended to include a heterogeneous material description together with a strain-based criterion for crack initiation. The model was tested on two femurs, previously mechanically tested in vitro. Our results illustrate the importance of implementing a subject-specific material distribution to capture the experimental fracture pattern under stance loading. Our models accurately predicted the fracture pattern and bone strength (1% and 5% error) in both investigated femurs. This is the first study to simulate complete fracture paths in subject-specific FE femur models and it demonstrated how discrete damage models can provide a more complete picture of fracture risk by considering both bone strength and fracture toughness in a subject-specific fashion.

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.