Purpose of study. The aim is to assess the use of non-fusion instrumentation “growth rods” in early onset scoliosis (EOS). Methods. A retrospective review of 12 consecutive patients who had undergone a growth rod procedure for EOS was performed. Six patients had neuromuscular scoliosis, 5 had juvenile idiopathic scoliosis while one had a congenital aetiology. Growth constructs were predominately constructed from modular commercially available sets using hooks, screws and connection blocks. One VEPTR was used in a severe kyphoscoliosis. Patients returned to theatre at 6 monthly intervals for a lengthening procedure. Patients were assessed with regards to age at presentation, age at surgery, indications for surgery, initial Cobb angle, post- operative Cobb angle, number of lengthening's done, instrumentation used, amount of spine growth achieved and complications. Results. The average age at presentation was 3 yrs 8 months (birth – 7 years 5 months). The average Cobb angle was 55 (38–90). Age at index surgery ranged from 2yrs 9 months to 8 years 2 months. The Cobb angle after the first procedure averaged 37 (range 20–90). The average lengthening over 51 lengthening procedures was 8 mm. Four patients have reached the end of the process and under gone a definitive fusion with pedicle screws and growth rods. Their final Cobb angle averaged 32 (26–48). Definitive surgery was performed earlier than planned in one patient due to repetitive rod breakage. Lengthening was abandoned in one patient whose implants became septic and required removal. Two patients required revision for superior construct failure. Conclusion. The growth rod procedure allows spinal deformity correction and control as well as on-going growth in trunk height. It is a labour intensive process with a significant incidence of complications. There is however very little choice in these patients due to concerns of fusion restricting pulmonary development. NO DISCLOSURES

Aims

Magnetically controlled growing rods (MCGR) have been gaining popularity in the management of early-onset scoliosis (EOS) over the past decade. We present our experience with the first 44 MCGR consecutive cases treated at our institution.

Aims. The primary aim of this study was to evaluate the performance and safety of magnetically controlled growth rods in the treatment of early onset scoliosis. Secondary aims were to evaluate the clinical outcome, the rate of further surgery, the rate of complications, and the durability of correction. Patients and Methods. We undertook an observational prospective cohort study of children with early onset scoliosis, who were recruited over a one-year period and followed up for a minimum of two years. Magnetically controlled rods were introduced in a standardized manner with distractions performed three-monthly thereafter. Adverse events which were both related and unrelated to the device were recorded. Ten children, for whom relevant key data points (such as demographic information, growth parameters, Cobb angles, and functional outcomes) were available, were recruited and followed up over the period of the study. There were five boys and five girls. Their mean age was 6.2 years (2.5 to 10). Results. The mean coronal Cobb angle improved from 57.6° (40° to 81°) preoperatively, 32.8° (28° to 46°) postoperatively, and 41° (19° to 57°) at two years. Five children had an adverse event, with four requiring return to theatre, but none were related to the device. There were no neurological complications or infections. No devices failed. One child developed a proximal junctional kyphosis. The mean gain in spinal column height from T1 to S1 was 45.4 mm (24 to 81) over the period of the study. Conclusion. Magnetically controlled growth rods provide an alternative solution to traditional growing rods in the surgical management of children with early onset scoliosis, supporting growth of the spine while controlling curve progression. Their use has clear psychosocial and economic benefits, with the reduction of the need for repeat surgery as required with traditional growing rods. Cite this article: Bone Joint J 2018;100-B:507–15

Aims. To investigate metallosis in patients with magnetically controlled growing rods (MCGRs) and characterize the metal particle profile of the tissues surrounding the rod. Methods. This was a prospective observational study of patients with early onset scoliosis (EOS) treated with MCGRs and undergoing rod exchange who were consecutively recruited between February 2019 and January 2020. Ten patients were recruited (mean age 12 years (SD 1.3); 2 M:8 F). The configurations of the MCGR were studied to reveal the distraction mechanisms, with crucial rod parts being the distractable piston rod and the magnetically driven rotor inside the barrel of the MCGR. Metal-on-metal contact in the form of ring-like wear marks on the piston was found on the distracted portion of the piston immediately outside the barrel opening (BO) through which the piston rod distracts. Biopsies of paraspinal muscles and control tissue samples were taken over and away from the wear marks, respectively. Spectral analyses of the rod alloy and biopsies were performed to reveal the metal constituents and concentrations. Histological analyses of the biopsies were performed with haematoxylin and eosin staining. Results. Titanium (Ti), vanadium (V), and neodymium (Nd) concentrations in the biopsies taken near the wear marks were found to be significantly higher than those in the control tissue samples. Significantly increased Nd concentrations were also found in the tissues near the barrel of the MCGR. Chronic inflammation was revealed by the histological studies with fibrosis and macrophage infiltration. Black particles were present within the macrophages in the fibrotic tissues. Conclusion. Ti and V were generated mainly at the BO due to metal-on-metal contact, whereas the Nd from the rotor of the MCGR is likely released from the BO during distraction sessions. Phagocytotic immune cells with black particles inside raise concern regarding the long-term implications of metallosis. Cite this article: Bone Joint J 2020;102-B(10):1375–1383

Aims

The aim of this study was to compare outcomes after growth-friendly treatment for early-onset scoliosis (EOS) between patients with skeletal dysplasias versus those with other syndromes.

Aims

The aim of this study was to compare the clinical and radiological outcomes of patients with early-onset scoliosis (EOS), who had undergone spinal fusion after distraction-based spinal growth modulation using either traditional growing rods (TGRs) or magnetically controlled growing rods (MCGRs).

Aims

We present a case series of five patients who had revision surgery following magnetic controlled growing rods (MGCR) for early onset scoliosis. Metallosis was found during revision in four out of five patients and we postulated a mechanism for rod failure based on retrieval analysis.

Aims

We undertook a prospective non-randomised radiological study to evaluate the preliminary results of using magnetically-controlled growing rods (MAGEC System, Ellipse technology) to treat children with early-onset scoliosis.

Aims

Magnetically controlled growing rod (MCGR) systems use non-invasive spinal lengthening for the surgical treatment of early-onset scoliosis (EOS). The primary aim of this study was to evaluate the performance of these devices in the prevention of progression of the deformity. A secondary aim was to record the rate of complications.

Abstract. MAGnetic Expansion Control (MAGEC) rods are used in the surgical treatment of children with early onset scoliosis. The magnetically controlled lengthening mechanism enables rod distractions without the need for repeated invasive surgery. The CE certification of these devices was suspended in March 2021 due, primarily, to performance evidence gaps in the documents provided by the manufacturer to regulators and notified bodies. MAGEC rods are therefore not permitted for use in countries requiring CE marking. This was a survey of 18 MAGEC rod surgeons in the UK about their perception of the impact of the CE suspension on the clinical management of their patients. Unsurprisingly, virtually all perceived a negative impact, reflecting the complexity of this patient group. Reassuringly, these surgeons are highly experienced in alternative treatment methods. Cite this article: Bone Jt Open 2022;3(2):155–157

Background: To assess the potential for Quantec imaging to save radiographs in the follow-up of patients with early onset scoliosis. This is a group of patients who often have many radiographs due their age at diagnosis. Methods: This is a prospective cohort study. Twenty-four children with early onset scoliosis are identified. They all have a minimum of three simultaneous radiographs and Quantec scans as part of routine follow up for their scoliosis curves. There are 15 males and 9 females (22 thoracic, 1 thoracolumbar, 1 lumbar). Mean age at diagnosis is 3 years (range 1–4.8 years). The Cobb angle of the major curve is measured from each radiograph and compared with the Q-angle using Bland-Altman plots and linear regression analysis. Results: The mean Cobb angle was 30° and the mean Q-angle 19°. The correlation coefficient was 0.68 (p< 0.05). In curves with Cobb angle < 30°, The Bland-Altman plots show a close scatter with a mean difference of 3.4°. It was calculated that this could have safely saved 18 radiographs in 14 patients. In curves > 30°, there was a large scatter and a mean difference between Cobb angle and Q-angle of 20.1°. Conclusion: In early onset scoliosis, curves with Cobb angle less than 30° can be safely followed clinically and with the Q-scan reducing the number of radiographs required. Curves with Cobb angle greater than 30° cannot be reliably observed with Quantec scans alone

We present a large single surgeon case series evaluation of a new growth guidance technique for the treatment of progressive early onset scoliosis (EOS). A traditional Luque trolley construct uses wires to hold growth guidance rods together. We describe a new technique that uses domino end to side connectors in place of the wires with the aim of providing a stronger construct to better limit curve progression, while allowing longitudinal growth. We did a thorough retrospective review of patient records and radiological imaging. Sequential measurements of Cobb angle and length of rods were recorded, as well as any further surgical procedures and associated complications. This enabled us to quantify the ability of a technique to limit curve progression and simultaneously allow growth of the construct. In total, 28 patients with EOS (20 idiopathic, four syndromic, and four neuromuscular) have been treated with this technique, 25 of whom have a minimum follow-up of 2 years and 13 have a minimum follow-up of 5 years. The average correction of the preoperative Cobb angle was 48.9%. At the 2-year follow up, the average loss of this initial correction was 15 degrees, rising to only 20 degrees at a minimum of 5 years (including four patients with a follow-up of 8 years or more). The growth of the constructs was limited. The average growth at 2 years was 3.7 mm, rising to 19 mm at the 5-year follow-up. Patients who underwent surgery with this technique before the age of 8 years seemed to do better. This group had a revision rate of only 18% at an average time of 7 years after the index procedure, and the average growth was 22 mm. However, the group that had index surgery after the age of 8 years had a 64% revision rate at an average of 3.2 years after surgery and an average growth of only 11.6 mm. Overall, in the cases series, there were four hardware failures (14%) and one deep infection (3.5%), and only ten patients (36%) had one extra surgery after the index procedure. Only two of the 13 patients who are at a follow-up of 5 years or more have had revision. This modified Luque trolley technique has a good capacity for initial curve correction and for limiting further curve progression, with limited longitudinal growth before 2 years and improved growth thereafter. This technique might not be so useful after the age of 8 years because of poor growth and a higher early revision rate. We have also demonstrated a low cost technique with a low hardware failure rate that saves many future surgeries for the patient compared with other techniques used in the treatment of EOS

Introduction. The aim of the treatment of children with early onset scoliosis is controlling growth of the spine. Whatever the etiology, early progressive deformations require multiple stages of surgery usually performed every 6–12 months. One have to be reckoned with complications requiring additional surgical intervention. Objective. The aim of the study is to present a new method of surgical treatment of early onset scoliosis involving the implantation of specially constructed implants to allow three dimensional correction of spinal deformity with a preserved capacity to continue the growth of spine without distraction staged operations followed by final spondylodesis in mature spine. Material. The clinical material consists of homogeneous group of patients: 8 girls and a one boy aged 6 to 14 years (mean age = 9 years). The estimated group four children had a single-curve, four children had a double-curve, while one child was affected by congenital kyphosis. The follow up ranged from 2 to 17 months (mean = 13.5 months). Method. Efficacy of spinal deformity correction using a “growing implants” was estimated by Cobb andgle measurement of the curvature 1/before the operation, 2/after surgery and 3/follow up. Results. During surgery, all patients obtained a large correction of curvature ranging from 50% to 100% (on average −70%). The degree of correction was directly dependent on the size of the initial deformation of 62 to 120 ° (average 77 °). During the entire period of observation in four children we have not identified the loss of correction or fits within the limits of measurement error. In one child thirty degree-loss correction stemmed from too selective implantation of the implants. During additional surgery the stabilization was extended to the extra two motor segments witch resulting in full correction. In one patient, due to rapid growth, rods were needed to be replaced for longer, because of the risk of pulling out from the lower screws. In one case we observed further correction during follow up. Conclusions. Using the method we obtained a very good correction in the first stage of treatment. Maintenance of correction does not require any intermediate staged operating procedures. Patients do not require corrective brace. Using “growing implants” in the early onset scoliosis one avoid complications peculiar to current growth-sparing procedures. These patients would have had 15 lengthening procedures after their initial correction if treated by conventional growing rod methods

Background: To assess the use of subcutaneous rodding with sequential lengthening procedures to control progressive early onset curves not responding to conservative treatment modalities. Methods: A retrospective study reviewing the notes and plain radiographs of all children with early onset scoliosis treated by growth rod insertion over a seven year period (two paediatric spinal surgeons using similar techniques at two major centres). Subjects were children with early onset scoliosis unresponsive to conservative management. Outcome measures – curves at time of instrumentation, curve progression, number of lengthenings, curve magnitude and age at time of definitive fusion, spinal growth achieved and complications encountered. Results: Majority of children treated uneventfully with satisfactory control of curvature until age at which definitive fusion acceptable. However our results do suggest a number of cases and circumstances where simple growth rod instrumentation is not sufficient and augmentation with anterior apical fusion is required (will discuss these on an individual basis). Conclusion: The management of early onset progressive scoliosis by means of growth rod instrumentation and sequential lengthenings is safe and effective

Spinal Deformity Service, Royal Orthopaedic Hospital, Birmingham, UK. To describe the technique of nonfusion annulotomy and nuclectomy with posterior growing rod instrumentation for the treatment of non-congenital early onset scoliosis. To present our results of the application of this technique in a consecutive series of nine patients with mean follow up of 76 months (range 16 to 123 months). We undertook retrospective observational casenote and radiograph study of patients with noncongenital early onset scoliosis having annulotomy and nuclectomy at the apex of their respective curves with standard posterior growing rod instrumentation between 1998 and 2009. 10 patients were identified with one excluded due to short follow up period. Of the nine patients included mean follow up was 76 months. Mean age at primary surgery was 71.7 months (range 29- 97 months). We measured pre and post operative Cobb angle, T1-S1 height change and change in height over the apical segments. Mean pre op cobb angle was 74° (range 62- 81°). Mean post op cobb angle was 38°. Three patients have completed their treatment programme with a mean number of 9 lengthenings achieved. Six patients are still undergoing lengthenings. CT demonstrates that the annulotmized segment does not fuse at a mean 3.5 years postoperatively. All patients demonstrated growth over total spinal height and also over apical segments which had undergone annultomy/ nuclectomy. We also report complications. We have demonstrated that anterior annulotomy and nuclectomy with posterior growing rod construct does allow for spinal growth over released segments without autofusion

Summary Statement. Novel radiopaque UHMWPE sublaminar cables may be a promising alternative to gliding pedicle screws or titanium sublaminar cables within a growth-guidance system for the surgical treatment of early onset scoliosis. Introduction. Growth-guidance or self-lengthening rod systems are an alternative to subcutaneous growing rods and the vertical expandable prosthetic titanium rib for the treatment of early onset scoliosis. Their main perceived advantage over growing rods is the marked decrease in subsequent operative procedures. The Shilla growth-guidance system and a modern Luque trolley are examples of such systems; both depend on gliding pedicle screws and/or sliding titanium sublaminar wires. However, the unknown consequences of metal-on-metal wear debris are reason for concern especially in young patients. In this study, instrumentation stability, residual growth in the operated segment after surgery and biocompatibility of the novel radiopaque UHMWPE cables as an alternative to gliding pedicles screws or titanium sublaminar wires were assessed in an immature sheep model. Materials and methods. Twelve immature sheep were treated with segmental sublaminar spinal instrumentation: dual CoCr rods were held in place by pedicle screws at the most caudal instrumented level (L5) and novel radiopaque UHMWPE (Bi. 2. O. 3. additive) woven cables were placed at 5 thoracolumbar levels. Lateral radiographs were taken at 4-week intervals to evaluate growth of the instrumented segment. Four age-matched, unoperated animals served as radiographic control. After 24 weeks follow-up, the animals were sacrificed and the spines were harvested for histological evaluation and CT analysis. Results. No neurological deficits and no complications occurred during the initial postoperative period. One animal died during follow-up due to unknown cause. At sacrifice, none of the cables had loosened and the instrumentation remained stable. Substantial growth occurred in the instrumented segment (L5-T13) in the intervention group. No significant difference in growth of the operated segment was found between the intervention and control groups. Histological analysis showed fibrous encapsulation of the novel radiopaque UHMWPE sublaminar cable in the epidural space, with no evidence of chronic inflammation. Discussion. Novel radiopaque UHMWPE cables may be a promising alternative to gliding pedicle screws or titanium sublaminar cables within a growth-guidance system. UHMWPE cables may improve growth results due to the smooth surface properties of the UHMWPE cable and address concerns regarding the consequences of metal-on-metal wear debris

Purpose. The aim of this study is to assess the safety and efficacy of a remote-operated magnetic growth rod in the treatment of 11 patients with progressive early onset scoliosis (EOS). Introduction. The Growth rod technique (GR) has been a viable treatment option for progressive early onset scoliosis (EOS). However, an increased complication rate has been associated with conventional GR due to frequent surgeries required for lengthening. The safety and efficacy of a remote-operated magnetic growth rod (RO-MGR) has been previously reported in a porcine model. We are reporting the preliminary clinical results of this device which obviates the need for repeated surgeries. Methods. Prospective analysis of early clinical and radiographic data of 11 patients, with EOS, undergoing index RO-MGR treatment and at least 3 distractions. The mean age was 8 years (Range 5-12 years). Four patients had single rod (SR) instrumentation and the remaining 7 had a dual rod (DR) construct. Diagnosis was idiopathic 3, neuromuscular 3, congenital 3, syndromic 1 and neurofibromatosis one. In total, 57 rod distractions were performed. Distractions were performed in the clinic without anesthesia or analgesics. The mean preoperative Cobb angle was 68° (range 46°-108°). The mean preoperative T1-S1 length was 304mm (range 243-361mm). Results. Average distraction was 3.2 per patient. The mean lag before the first distraction was 66 days (28-112) and between distractions was 43 days (42-98). Superficial infection occurred in 1 (SR), prominent rod in 1 (DR), hook pull-out in 1(DR), iatrogenic shortening 1(DR) and loss of length in 2 patients (6/57 rod distraction, 11%, all SR), this loss was regained in subsequent distractions. Apart from a case of proximal rod trimming, no further surgery was required in our group of patients. Mean follow-up was 8 months (6-13). Conclusion. Preliminary results indicate that RO-GR appears to be safe and provided a comparable distraction to the standard GR procedure without the need for repeated open surgeries. No major complications were observed in the short follow up period

Scoliosis is estimated to occur between 21–64% of patients with cerebral palsy (CP), where a subset of patients develops early onset scoliosis (EOS) before the age of ten. Traditional growth friendly (TGF) surgeries in the context of traditional growing rods have been shown to be effective in treating scoliosis in this population, however significant complication rates are reported. Currently, no studies have been done to examine the effect of novel growth friendly surgeries such as magnetically controlled growing rods (MCGR) on EOS in CP patients. The objective of this study is to compare MCGR with TGF surgeries in this patient population, specifically by evaluating radiographic measurements and risk of unplanned reoperations (UPRORs). Patients with EOS secondary to CP were prospectively identified from an international database, with data retrospectively analyzed. Scoliosis (primary curve), maximum kyphosis, T1-S1 and T1-T12 height were measured pre-operation, immediate post-operation, and at two-years follow-up. The risk and etiology of UPRORs were compared between MCGR and TGF. P < 0.05 was considered statistically significant for all analyses. Of the 120 patients that met inclusion criteria, 86 received TGF (age 7.5 ± 1.8 years; follow-up 7.0 ± 2.9 years) and 34 received MCGR (age 7.1 ± 2.2 years, follow-up 2.8 ± 0.5 years). Compared to TGF, MCGR resulted in significant improvements in maintenance of scoliosis correction (p=0.04). At final follow-up, UPRORs were 24% for MCGR (8/34 patients) and 43% (37/86 patients) for TGF (p=0.05). To minimize the influence of follow-up period, UPRORs within the first two years post-operation were evaluated: MCGR (21%, 7/34 patients) vs. TGF (14%, 12/86 patients; p=0.37). Within the first two years, etiology of UPROR as a percentage of all patients per group were deep infection (5% TGF, 6% MCGR), implant failure/migration (5% TGF, 9% MCGR), dehiscence (2% TGF, 3% MCGR), and superficial infection (1% TGF, 3% MCGR). The most common etiology of UPROR for TGF was deep infection and implant failure/migration and for MCGR was implant failure/migration. For patients with CP, at final follow-up, MCGR had superior maintenance of scoliosis correction; however, there was no difference in risk of UPROR within the first two years post-operatively (21% MCGR, 14% TGF)

Intrathecal morphine (IM) is a common adjunct in paediatric spinal deformity surgery. We previously demonstrated with idiopathic scoliosis it provides safe and effective analgesia in the immediate postoperative period. This study represents our 25 year experience with IM in all diagnostic groups. Our prospective Pediatric Orthopaedic Spine Database (1993–2018) was reviewed to identify all patients undergoing spinal deformity surgery who received IM and who did not. Patients 21 years of age or less who had a posterior spinal fusion (PSF) with segmental spinal instrumentation (SSI), and received 9–19 mcg/kg (up to 1 mg) of IM were included. Early onset scoliosis surgical patients were excluded. We assessed demographics, pain scores, time to first dose of opioids, diagnoses, surgical time, paediatric intensive care unit (PICU) admission and IM complications (respiratory depression, pruritus, nausea/ vomiting). There were 986 patients who met inclusion criteria. This included 760 patients who received IM and 226 who did not. IM was not used for short procedures (< 3 hrs), respiratory concerns, unsuccessful access of intrathecal space, paraplegia, and anesthesiologist decision. Both groups followed the same strict perioperative care path. The patients were divided into 5 diagnostic groups (IM / non IM patients): idiopathic (578/28), neuromuscular (100/151), syndromic (36/17), and congenital scoliosis (32/21) and kyphosis (14/9). Females predominated over males (697/289). The first dose of opioids after surgery was delayed for a mean of 10.6 hrs in IM group compared to 2.3 hrs in the non-IM group (p=0.001). The postoperative pain scores were significantly lower in the IM groups in the Post Anesthesia Care Unite (p=0.001). Only 17 IM patients (2%) were admitted to the PICU for observation secondary to respiratory depression, none required re-intubation. None of the IM group were re-intubated. Forty-nine patients (6%) experienced pruritus in the IM group compared to 4 of 226 patients (2%) in the non IM group. There were 169 patients (22%) of the IM patients and 21 patients (9%) of the non IM had nausea and vomiting postoperatively. Three patients (0.39%) had a dural leak from the administration of IM but did not require surgical repair. There were no other perioperative complications related to the use of IM. There were no significant group differences. Pre-incision IM is a safe and effective adjunct for pain management in all diagnostic groups undergoing spinal surgery. The IM patients had lower pain scores and a longer time to first administration of post-operative opioids. Although there is an increased frequency of respiratory depression, pruritus, and nausea/vomiting in the IM group, there were no serious complications

STUDY DESIGN. Retrospective study of 8 children treated with vertical expandable prosthetic titanium rib (VEPTR) for correction of early onset spinal scoliotic deformities. METHODS. 8 children with progressive scoliosis due to a variety of conditions, 6 congenital (2 Goldenhar syndrome, 2 VACTERL syndrome, 2 congenital thoracic abnormalities), 1 spondyloepiphyseal dysplasia, 1 early onset of scoliosis, underwent the index procedure and subsequent lengthening procedures at 6 months intervals (1 patient had 11 lengthening procedures). Mean age was 4 years (2-6 years) and mean follow up 3.8 years (2-6 years). Mean preoperative Cobb angle was 64,8° (51-108) and mean postoperative angle 40° (31-50). RESULTS. There were no neurological complications. Three patients developed infection with wound breakdown. One patient underwent removal of one of the two VEPTR rods. In the other two patients the rods were removed followed by antibiotics and the VEPTR converted to another growing rod system. Overall, patients tolerated the multiple procedures well. Three patients experienced significant distress with multiple surgical procedures. CONCLUSION. VEPTR offers a viable treatment option for children with severe congenital and early onset scoliosis where there are no viable alternatives. It achieves and maintains spinal deformity correction, while allowing for continued spine and chest-wall growth. Complication rate is acceptable in view of the benefits. None of the complications have lead to long term complications to date, but the repeated lengthening have resulted in psychological disturbance which we are investigating further. An implantable driver would offer very significant advantages and would avoid some of the repeated operations