Magnetically Controlled Growing Rods Research Articles

Posterior Column Release and Lengthening with a Magnetic Growing Rod Construct in Severe Congenital Thoracic Fusion: A Report of 2 Cases.

We describe treatment of severe multilevel congenital thoracic fusion in a 3-year-old girl with Apert Syndrome by posterior element excision, posterior column osteotomies, and gradual distraction with magnetically controlled growing rods (MCGR) with 3-year follow-up. We also describe short-term follow-up with similar management in an 8-year-old patient with a congenitally fused thoracic spine from Jarcho-Levin syndrome. Posterior element resection and targeted posterior column osteotomies combined with gradual distraction with MCGR offers a promising treatment course for children with severe thoracic insufficiency syndrome derived from congenital fusions.

Awareness of Current Surgical Practice for Congenital Scoliosis and Optimal Timing of Treatment Among Physicians and Patients' Families in Saudi Arabia.

Congenital scoliosis (CS) is a developmental spinal deformity characterized by an abnormal curvature of the spine, affecting one in 1,000 births. The mainstay of treatment involves either observation or surgery in significant curve progression. The optimal timing of surgical intervention is debated, with early intervention preferred. Therefore, understanding physicians' and patients' families' perspectives is crucial for optimizing surgical outcomes in CS. To assess the awareness and knowledge of physicians and patients' families regarding current, as well as new surgical practices and the optimal timing of treatment for CS. A cross-sectional study was conducted in Saudi Arabia using an online self-administered questionnaire distributed through social media platforms and neurosurgery clinics. Levels of awareness were assessed by a knowledge-scoring system. The study involved 403 participants, primarily patients' families (85.1%, N = 343) and physicians (14.9%, N = 60). The results show that physicians had a significantly higher correct response than patients' families regarding the ideal age for surgical correction of CS, the timing of surgical intervention whether before or after maturity, and the role of conservative management, as evident from statistically significant p-values of <0.001, 0.031, and <0.001, respectively. On the contrary, patients' families excelled in understanding interventions irrespective of symptomatic status if Cobb's angle is 40 degrees or above, with a statistically significant p-value of 0.031. Both groups exhibited a good level of overall knowledge, as evidenced by mean awareness scores of 12.18 and 11.64, respectively. Additionally, physicians had a statistically significanthigher level of awareness compared to patients' families, with a p-value of (0.014). However, both groups demonstrated poor knowledge of the latest techniques, including distraction-based magnetically controlled growing rods (MCGRs), growth-guided modern Luque trolleys, and posterior dynamic deformity correction (ApiFix). The mean awareness score of both physicians and patients' families indicates a good level of knowledge. However, both groups exhibited poor knowledge in relation to the optimal timing of treatment and new surgical techniques.

Patient-perceived factors on treatment satisfaction in early onset scoliosis treated surgically with a minimum of ten years

BackgroundThe prognosis of surgically treated subjects with early onset scoliosis (EOS) into adulthood has been lacking. We aimed to investigate the patients’ perspectives on satisfaction with surgical treatment.MethodologyWe included all surgical candidates with EOS who had undergone index spinal surgery for scoliosis correction between 2009 and 2013. The minimum duration of postoperative follow-up was 10 years at the time of survey completion. Three questionnaires were used in this study, comprising the revised Scoliosis Research Society questionnaire (SRS-22r), the Patient-Reported Outcomes Measurement Information System (PROMIS-29), and the World Health Organization Quality of Life (WHOQOL-BREF). Measures of treatment satisfaction were retrieved from SRS-22r.ResultsThere were 29 participants who completed the survey, and thereby included in the study (i.e., a response rate of 43% and a dropout rate of 6%). Amongst them, 14, 11, and 4 individuals received posterior spinal fusion (PSF), magnetically controlled growing rods (MCGR), and traditional growing rods, respectively. The average duration after the index spinal surgery was 12.6 ± 2.2 years. Our findings revealed that self-image (across all treatment groups), sleep disruption (only in PSF), and social aspects (in both PSF and MCGR) were significantly worse when compared to the normative values. According to the multivariable linear regression model (R-square = 0.690, p < .001), an increase in SRS-22r mental health (p = .008) and PROMIS-29 social participation scores (p = .004) corresponded to 0.511 and 0.055 points increases in satisfaction. Every unit increase in PROMIS-29 fatigue (p = .043) and WHOQOL-BREF physical domain scores (p = .007) was in conjunction with 0.019 and 0.040 points decreases in satisfaction. SRS-22r self-image (p = .056) and WHOQOL-BREF environmental domain scores (p = .076) were included in the model but did not reach statistical significance.ConclusionsTo improve the long term quality of life in surgical candidates with EOS, we demonstrated that mental health, social participation, fatigue, and physical health were significant factors associated with treatment satisfaction. Interestingly, demographic and radiographic parameters did not have a significant effect in our cohort.

Proximal foundation anchor variations and their correlation with unplanned return to the operating room (UPROR) in children with EOS treated with magnetically controlled growing rods (MCGR).

The evolution of MCGR technique has led to modifications in the configuration of the proximal construct to decrease the incidence of implant-related complications (IRC) and revision surgeries. However, there is no data characterizing the performance of the most used configurations reducing the risk of complications. 487 patients were identified from an international multicenter EOS database. EOS patients, primary dual MCGR, complete radiographs, and minimum of 2-year follow-up. 76 patients had incomplete X-rays, 5 had apical fusions, and 18 had inconclusive complications, leaving 388 patients for review. A digital spine template was created to document UIV; number of levels; number, type, and location of anchors; as well as implant configuration. First available postoperative and latest follow-up radiographs were reviewed by two senior surgeons and two spine fellows. UPROR due to IRC was defined as any change in proximal anchors between the postoperative and final follow-up radiographs. The most common proximal construct configuration: UIV at T2 (50.0%) with 17.5% UPROR, followed by T3 (34.0%) with 12.1% UPROR; number of levels was three (57.1%) with 16.8% UPROR and two (26.0%) with 17.0% UPROR; number of proximal anchors was six (49.9%) with 14.1% UPROR and four (27.0%) with 18.3% UPROR. The most common anchors were all screws (42.0%) with 9.9% UPROR, and all hooks (26.4%) with 31.4% UPROR (P < 0.001). The construct with the lowest rate of UPROR was a UIV at T2, with six anchors (all screws) across three levels (42 cases), with 0% UPROR. Other construct combinations that yielded 0% UPROR rates were UIV of T3, six anchors (all screws) across three levels (25 cases), and a UIV of T3 with six anchors (screws and hooks) across three3 levels (9 cases). Proximal anchor configuration impacts the incidence of UPROR due to IRC in MCGR. UIV at T2 and T3 compared to T4, and the use of all screws or combination of screws and hooks compared to all hooks were associated with a lower UPROR rate. The most common construct configuration was T2 UIV, three levels, six anchors, and all screws. The use of a combination of six anchors (screws or screws and hooks) across three levels with a UIV at T2 or T3 was associated with a lower UPROR rate.Additional research is needed to further evaluate the variables contributing to configuration selection and their association with IRC.

Complications and Health-Related Quality of Life in Children with Various Etiologies of Early-Onset Scoliosis Treated with Magnetically Controlled Growing Rods-A Multicenter Study.

Background: Early-onset scoliosis (EOS) refers to spinal deformities that develop and are diagnosed before the age of 10. The most important goals of the surgical treatment of EOS are to stop the progression of curvature, achieve the best possible correction, preserve motion, and facilitate spinal growth. The objectives of this multicenter study were to analyze the risk of complications among patients with EOS treated using magnetically controlled growing rods (MCGRs) and assess the patients' and their parents' quality of life after diagnosis and treatment with a minimum two-year follow-up. Methods: Patients given an ineffective nonoperative treatment qualified for surgery with MCGRs. This study involved 161 patients (90 females and 71 males) who were classified according to the etiology of curvature. The intraoperative and postoperative complications and those that occurred during the continuation of treatment with MCGRs were recorded and analyzed. The 24-item Early-Onset Scoliosis Questionnaire (EOSQ-24) was used to evaluate the patients' quality of life and satisfaction with the treatment. Results: Implant-related complications requiring instrumentation revision were recorded in 26% of the patients. Medical complications occurred in 45% of the population. The EOSQ-24 revealed a significant improvement in the average scores during the follow-up. Conclusions: The treatment of early-onset scoliosis with MCGRs carries 66% risks of incurring medical and mechanical complications, the latter 26% of patients requiring revision procedures. Children with neuromuscular scoliosis, females, and with curvature greater than 90 degrees are at a higher risk of developing complications. Limiting the number of elective surgeries necessitated to prolong the instrumentation and treatment process for patients with MCGRs can greatly enhance their quality of life and satisfaction throughout the follow-up period.

Increased lengthening frequency does not adversely affect the EOSQ scores in magnetically controlled growing rod surgeries in 133 subjects followed to final fusion.

Magnetically Controlled Growing Rod (MCGR) allows frequent outpatient rod lengthening when treating Early Onset Scoliosis (EOS) patients. But there is lack of expert consensus on the optimal MCGR lengthening interval. EOS 24-Item Questionnaire (EOSQ) is validated for assessing health-related quality of life (HrQOL), family burden, and satisfaction. This is the first study assessing how MCGR lengthening intervals affects patient-perceived outcomes. This is a multicentred cohort study with subjects recruited from 2012 to 2018 and followed till fusion. EOS subjects who underwent MCGR surgeries were grouped into high, mediumor low lengthening interval subgroups based on 16 and 20week cut-offs. Repeated measure analysis was performed on EOSQ's specified 12 domains. EOSQ results were taken: before index surgery, after index surgery, and prior to definitive treatment. Demographic, clinical and radiographic data were included in model adjustment. 133 subjects with mean follow-up of 3.5 (± 1.3)years were included, with 60 males and 73 females; 45 idiopathic, 23 congenital, 38 neuromuscular, and 27 syndromic patients. Mean Cobb angle at surgery was 67° (± 22°) with mean age of 8.3 (± 2.5)years. Between groups, clinical and radiographic parameters were comparable. Higher EOSQ scores in mediumlengthening interval subgroup was present in fatigue (p = 0.019), emotion (p = 0.001), and parental impact (p = 0.049) domains, and overall score (p = 0.046). Trendline contrast between subgroups were present in general health (p = 0.006) and physical function (p = 0.025) domains. Patient-perceived outcome improvements appear similar between lengthening interval subgroups. All MCGR lengthening intervals were tolerated by patients and family, with no negative impact observed. Prognostic Level III.

Pelvic Fixation for Non-Ambulatory Patients with Neuromuscular Scoliosis Treated with Magnetically Controlled Growing Rods-A 4-Year Comparison of Two Different Fixation Methods.

Background/Objectives: This study aims to analyze the efficacy and safety of the two pelvic fixation systems, S-hooks (SH) and lumbar-sacral-alar-iliac (SAI) screws, when used in association with magnetically controlled growing rods (MCGRs) in non-ambulatory children with severe neuromuscular scoliosis (NMS). Methods: Forty-one patients were retrospectively examined and subdivided corresponding to ilium hook fixation or SAI screws. The major curve correction (%) and pelvic obliquity (PO) correction (%) were assessed utilizing scoliosis plain film radiographs over time. Complications and unplanned return to the operating room (UPROR) were recorded. Patient-specific pre- and postoperative values were included in a backward stepwise regression model to assess UPROR. Results: Mean age at index intervention was 9.4 years. Preoperative main curve was 81° and PO was 22°. 21 and 20 patients were categorized into the SH and SAI subgroups, respectively. Initial curve correction was significantly better in the SAI subgroup (63 vs. 42% in the SH, p = 0.045), while PO correction was equally good. Curve and PO correction were maintained throughout the follow-up period of 55 months. UPROR rate was 38% in the SH subgroup, and 5% in the SAI subgroup (p = 0.010). Regression analysis identified postoperative curve correction as predictive value for UPROR (p = 0.006). Conclusions: SAI screw fixation has a low UPROR rate and achieves superior curve correction. S-hooks are a viable option to correct PO and NMS in children with high operative risk to reduce operative time, but revision surgery is not uncommon.

Impact of Spinal Surgery on Intrathecal Nusinersen Injections in Pediatric Spinal Muscular Atrophy.

Complex spinal deformities necessitate surgical interventions that may intervene with intrathecal injections in patients with spinal muscular atrophy (SMA). This study aimed to determine the effect of spinal deformity correction surgery on nusinersen administration. Pediatric patients with SMA, operated by a single surgeon, either via magnetically controlled growing rod (MCGR) or definitive fusion (DF) with skip instrumentation, were evaluated retrospectively in terms of safety and feasibility of intrathecal injections. Patients' and their parents' perspectives were evaluated through a questionnaire regarding any shift in the setting of injections. Fourteen patients with 15 spinal surgeries (10 MCGR and 5 DF) were included. Eleven patients received intrathecal treatment both before and after the surgery. Preoperative (n=3) and postoperative (n=9) fluoroscopic guidance was required leading to a shift in the application settings in 6 patients. Of 106 preoperative injections, 15% required fluoroscopy and 2% required anesthesia. Postoperatively, of 88 injections, 73% required fluoroscopy and 26% required anesthesia. No patients discontinued intrathecal injections due to technical difficulties associated with the spinal surgery. This study demonstrates that spinal surgery does not prevent safe and successful intrathecal nusinersen injections. In the DF group, the skip instrumentation technique provided access to interlaminal space for intrathecal injections. In either surgical group, no further auxillary approach was required. Modifications in the injection technique require an institutional approach, and concerns of patients and their families should be addressed accordingly. IV.

Unplanned return to the operating room (UPROR) occurs in 40% of MCGR patients at an average of 2years after initial implantation.

This study calculated the rates of Unplanned Return to the Operating Room (UPROR) in early-onset scoliosis patients who had no previous spine surgery and underwent Magnetically Controlled Growing Rod (MCGR) implantation. We reviewed surgical, radiographic, and UPROR outcomes for EOS patients treated with the MCGR implant < 12years + 11months of age, had complete preop/postop major curve measurements, and had complete MCGR details. 376 patients underwent MCGR implantation at a mean age of 7.7years (1.8-12.9). Diagnoses included 106 (28%) idiopathic, 84 (22%) syndromic, 153 (41%) neuromuscular, and 33 (9%) congenital. The mean preop-cobb was 76.7° (9-145°), and an immediate postop correction was 41% (0-84%). We found that 38% (142/376) of patients experienced an UPROR prior to the maximal actuator length being achieved. UPROR occurred at mean 2years (3days-5years) after initial implantation. Of the 142 patients who experienced UPROR there were 148 complications that lead to an UPROR. The most common reason for UPROR was anchor (55/148: 37%) or MCGR implant related (33/148: 22%). Wound related (22/148:15%), Neuro related 4/148: 3%), and other (34/148: 23%) accounted for the remaining UPROR occurrences. In conclusion, the MCGR UPROR rate was 142/376 (38%) after an average of 2years post implantation. At 2-year follow-up, only 20% of MCGR patients had experienced an UPROR. However, between 2 and 5years, the development of an UPROR increased precipitously with only 39% of MCGR patients remaining UPROR free at 5years post MCGR implantation. The most common reason for UPROR was related to anchor or MCGR implant-related complications. This information can be utilized to set realistic expectations about the need and timing of future surgical procedures with patients and their families.

Development of Consensus-Based Best Practice Guidelines for the Perioperative and Postoperative Care of Pediatric Patients With Spinal Deformity and Programmable Implanted Devices.

Modified Delphi consensus study. To develop consensus-based best practices for the care of pediatric patients who have implanted programmable devices (IPDs) and require spinal deformity surgery. Implanted programmable devices (IPDs) are often present in patients with neuromuscular or syndromic scoliosis who require spine surgery. Guidelines for monitoring and interrogating these devices during the perioperative period are not available. A panel was assembled consisting of 25 experts (i.e., spinal deformity surgeons, neurosurgeons, neuroelectrophysiologists, cardiologists, and otolaryngologists). Initial postulates were based on a literature review and results from a prior survey. Postulates addressed the following IPDs: vagal nerve stimulators (VNS), programmable ventriculoperitoneal shunts (VPS), intrathecal baclofen pumps (ITBP), cardiac pacemakers and implantable cardioverter-defibrillators (ICD), deep brain stimulators (DBS), and cochlear implants. Cardiologist and otolaryngologist participants responded only to postulates on cardiac pacemakers or cochlear implants, respectively. Consensus was defined as ≥80% agreement, items that did not reach consensus were revised and included in subsequent rounds. A total of 3 survey rounds and 1 virtual meeting were conducted. Consensus was reached on 39 total postulates across 6 IPD types. Postulates addressed general spine surgery considerations, the use of intraoperative monitoring and cautery, the use of magnetically controlled growing rods (MCGRs), and the use of an external remote controller to lengthen MCGRs. Across IPD types, consensus for the final postulates ranged from 94.4% to 100%. Overall, experts agreed that MCGRs can be surgically inserted and lengthened in patients with a variety of IPDs and provided guidance for the use of intraoperative monitoring and cautery, which varied between IPD types. Spinal deformity correction surgery often benefits from the use of intraoperative monitoring, monopolar and bipolar cautery, and MCGRs. The final postulates from this study can inform the perioperative and postoperative practices of spinal deformity surgeons who treat patients with both scoliosis and IPDs. V-Expert opinion.

The Surgical Management of Severe Scoliosis in Immature Patient with a Very Rare Disease Costello Syndrome-Clinical Example and Brief Literature Review.

Costello syndrome (CS) is a rare genetic syndrome in which, due to the occurrence of a mutation in the HRAS gene on chromosome 11 that causes the manifestation, a set of features such as a characteristic appearance, many congenital defects, intellectual disability and a genetic predisposition to cancer, friendly personality, and others can be identified. CS is very rare, with an incidence of ~1/300,000, but it belongs to one of the largest groups of congenital syndromes, called RASopathies, occurring with an incidence of 1/1000 people. Scoliosis and kyphosis, as well as other spinal defects, are common, in 63% and 58% of patients, respectively, and a study conducted among adult patients showed the presence of scoliosis in 75% of patients; there may be excessive lordosis of the lumbar section and inverted curvatures of the spine (lordosis in the thoracic section and kyphosis in the lumbar section). The aim of our study is to present a case report of treatment of severe scoliosis of 130 degrees in a 14-year-old patient with Costello syndrome, with coexisting Chiari II syndrome and syrinx in the absence of skeletal maturity. This patient underwent foramen magnum decompression 3 months before planned surgical correction for severe scoliosis. The patient was qualified for surgical treatment using magnetically controlled growing rods (MCGR). After spine surgery using MCGR, we gradually performed MCGR distraction over the next 2 years; we performed the final surgery, conversion to posterior spinal fusion (PSF) with simultaneous multi-level Ponte osteotomy, which gave a very good and satisfactory surgical result. In the perioperative period, two serious complications occurred: pneumothorax caused by central catheter and gastrointestinal bleeding due to previously undiagnosed gastrointestinal varices. This case shows that the treatment of severe and neglected scoliosis is complicated and requires special preparation and a surgical plan with other cooperating specialists. The scoliosis was corrected from 130 degrees to approximately 48 degrees, sagittal balance was significantly improved, and the surgical outcome was very pleasing, significantly improving quality of life and function for the patient.

Minimally Invasive Controlled Growing Rods for the Surgical Treatment of Early-Onset Scoliosis—A Surgical Technique Video

Background: Spinal deformities in children and adolescents can be easily divided into those occurring and diagnosed before the age of 10—early-onset scoliosis—and those occurring and diagnosed after the age of 10—late-onset scoliosis. When the curvature continues to progress and exceeds a Cobb angle of more than 60–65 degrees, surgical treatment should be considered. The most common treatment procedure for EOS is the surgical correction of the deformity using standard growing rods (SGRs), and in the case of congenital defects with additional hemivertebrae, it is the resection of the hemivertebra and short fusion. Minimally invasive controlled growing rods (MICGRs) need to be distracted every 6–9 months through a minimally invasive approach that involves sedation and neuromonitoring to obtain the best possible correction while minimizing complications. The aim of our study is to present a less-invasive surgical technique for MICGR implantation based on a two-case presentation—early-onset idiopathic scoliosis and congenital kyphosis. The surgical technique is the less-invasive percutaneous and subfascial implantation of MICGRs without long incisions in the back. Conclusions: The use of MICGRs is an alternative and safe surgical technique for patients undergoing surgical treatment for EOS. Without the risk of metallosis, like in other implant systems, and the need for replacement after 2 years of use, like in using magnetically controlled growing rods (MCGRs), the MICGR system can be used as a less-invasive procedure, allowing for the avoidance of many periodic invasive procedures in children with a wider opening of the spine (like in using standard growing rods), minimizing the number of planned hospitalizations, reducing the length of hospital stays, and reducing the physical and mental burdens on young patients, parents, and families.

Spinal height for growth guidance treatment in early onset idiopathic scoliosis: analysis through final surgical treatment.

The growth guidance (GG) method for treatment of early onset scoliosis has as its primary goal the restoration of apical spinal alignment, facilitating normal spinal growth to achieve a suitable adult thoracic height. To evaluate whether GG surgical treatment achieves comparable thoracic and spinal height to distraction-based treatment (DBT) in idiopathic early onset scoliosis (I-EOS) patients. We hypothesized that GG would prove superior to DBT at the time of definitive fusion surgery. All I-EOS patients who underwent GG at a single center were reviewed. T1-L1 and T1-S1 heights were measured using the traditional coronal method as well as the Halifax sagittal spinal length (SSL) technique. The same measurements were obtained from a comparable control group obtained from a multi-center pediatric early onset scoliosis database who underwent treatment with traditional growing rods (TGR) or magnetically controlled growing rods (MCGR). Of the I-EOS patients who underwent GG 2004-2019, 15 patients underwent final fusion after GG completion, with a mean 5.5years of GG treatment prior to fusion (range 2.0-11.4years). Mean age at GG implantation was 8.4years (range 2.0-11.7years); 7 were male and 8 female. GG patients experienced a mean coronal thoracic height increase of 6.2cm during treatment through final fusion, and a mean coronal spinal height increase of 8.8cm. At the time of final fusion, GG patients achieved greater significant mean increases than DBT patients by 2.9cm in coronal thoracic height (p = 0.0023), 4.5cm in coronal spinal height (p = 0.001), and 4.0cm in SSL spinal height (p = 0.01). No GG patient concluded treatment with a thoracic height less than 18cm in either coronal or sagittal plane. Not only did 100% of GG patients reach minimum thoracic height of 18cm at time of final fusion, but GG also proved to be superior to distraction-based constructs in a comparison cohort on 3 of 4 spinal elongation measures. 3.

Autofusion in early-onset scoliosis growing constructs: occurrence, risk factors, and impacts.

Autofusion (AF) during growing rod (GR) instrumentation for early-onset scoliosis (EOS) has been reported, but AF incidence, causation, and clinical implications remain unknown. This article aims to (1) quantify frequency and severity of AF, (2) determine risk factors for AF, and (3) assess the influence of AF on final curve correction and spinal lengthening. EOS patients were prospectively enrolled (2016-2021). Patients underwent evaluation, GR implantation, lengthenings, and posterior spinal fusion (PSF). Cobb angle and spinal length measurements were collected. AF was assessed and graded, with grades I-II being low-grade and III-V being high-grade. Exposure analysis quantified risk factors' impact via odds ratios and Pearson regression correlates. Statistical significance was p ≤ 0.05 or ≥ 0.95. 28 patients, with variable EOS diagnoses, were included. On average, GR were implanted at 8.54-year-old and lengthened over 4.66years. 53.6% of patients received magnetically controlled GR (MCGR) and 46.4% traditional GR (TGR). The average construct bridged 13.4 levels. Over the lengthening period, for all indications, patients averaged 2.9 total open procedures. Curves corrected from 68.5º preoperatively to 35.3º after index GR to 35.6º after PSF. Spinal length increased from 30.0cm preoperatively to 33.9cm after index GR to 39.5cm after PSF. AF grading was: 28.6% Grade I, 25.0% Grade II, 17.9% Grade III, 25.0% Grade IV, and 3.6% Grade V. Idiopathic EOS tended to have lower AF grades (p = 0.37). AF risk factors included GR age < 8 (10.4×, p = 0.01), any interval open procedures (6.3×, p = 0.05), and residual curve > 30º after index GR (13.7×, p = 0.02). Protective factors included preoperative spinal length of > 30.0cm (0.11×,p = 0.01) and index MCGR (0.16×, p = 0.03). Maintenance of Cobb angles from index GR through PSF was relatively better in low-grade patients (p = 0.08). Spinal length gained was no different between low- and high-grade AF (p = 0.50). This largest-to-date evaluation found AF is nearly ubiquitous in GR constructs, but with variable severity. Both risk factors and protective factors coincide with AF. Ultimately, even in high-grade AF, curve correction was maintained, and spinal lengthening was achieved. Level II-prospective cohort study.

Radiological Outcomes of Magnetically Controlled Growing Rods for the Treatment of Children with Various Etiologies of Early-Onset Scoliosis-A Multicenter Study.

Background: The management of spinal deformities diagnosed before the age of 10 is critical due to the child's development, skeletal system, and growth mechanism. Magnetically controlled growing rods (MCGRs) are a surgical treatment option for the growing spine. The aim of this study was to analyze the radiological findings of patients treated with MCGRs for early-onset scoliosis (EOS) of various etiologies. We hypothesized that the MCGRs could provide acceptable long-term radiographic results, such as an increase in the T1-T12 and T1-S1 height and significant overall deformity correction. Methods: We retrospectively reviewed 161 EOS patients with a combined total of 302 MCGRs inserted at five institutions between 2016 and 2022 with a mean follow-up of at least two years. The Cobb angle of the major curve (MC), thoracic kyphosis (TK), lumbar lordosis (LL), and T1-T12 and T1-S1 height measurements were assessed before, after, and during the follow-up. Results: Among the 90 female and 71 male patients, there were 51 neurological, 42 syndromic, 58 idiopathic, and ten congenital scoliosis etiologies. Of the patients, 73 were aged under six years old. The mean follow-up time was 32.8 months. The mean age at placement of the MCGRs was 7 years and that at the last follow-up after fusion surgery was 14.5 years. The mean MC before the initial surgery was 86.2°; following rod implantation, it was 46.9°, and at the last follow-up visit, it was 45.8°. The mean correction rate among the etiology subgroups was from 43% to 50% at follow-up. The mean TK was noted as 47.2° before MCGR implantation, 47.1° after MCGR placement, and 44.5° at the last follow-up visit. The mean T1-T12 height increased by 5.95 mm per year, with a mean T1-S1 height of 10.1 mm per year. Conclusions: MCGR treatment allowed for an average correction of the curvature by 50% during the period of lengthening, while controlling any deformity and growth of the spine, with a significant increase in the T1-T12 and T1-S1 values during the observation period. MCGR treatment in EOS carries a risk of complications. While congenital and syndromic EOS often have short and less flexible curves in those groups of patients, single rods can be as effective and safe. Definitive fusion results in the mean final coronal correction between the start of MCGR treatment and after undergoing PSF of approximately 70%. The mean T1-T12 spinal height increased by 75 mm, while the T1-S1 spinal height gained a mean of 97 mm.

Is posterior vertebral arthrodesis at the end of the electromagnetic rod lengthening program necessary for all patients? Comparative analysis of sixty six patients who underwent definitive spinal arthrodesis and twenty four patients with in situ lengthening rods.

Magnetically controlled growing rods (MCGR) should be removed or changed at most twoyears after their implantation in the treatment of patients with early-onset scoliosis (EOS) (Safety notice July 2021). However, in the face of patients at high risk of intraoperative complications and relying on the principle of auto-fusion of the spine, some surgeons would prefer a more wait-and-see attitude. The aim of this study was to report on patients who did not undergo final fusion at the end of the lengthening program with MCGR and to compare them with those who did. This was a multicenter study with ten centres. We collected all graduate patients with EOS who had received MCGR between 2011 and 2022. A total of 66 patients had final fusion at the end of the lengthening program and 24 patients kept MCGRs in situ. The mean total follow-up time was 66months (range, 25.3-109), and the mean follow-up time after final lengthening was 24.9months (range, 3-67.7). Regarding the main curve and thoracic height, there was no significant difference in the percentage of correction over the whole follow-up between the two groups (p = 0.099, p = 0.176) although there was a significant difference between the end of lengthening and the last follow-up (p < 0.001). After completion of the lengthening program, 18 patients who had final fusion developed 24 of the 26 recorded complications (92.3%). Contrary to the manufacturer's published safety notice, not all patients systematically benefited from the removal of the MCGRs. Although arthrodesis significantly improved the scoliotic deformity, no significant difference was found in terms of radiographic outcome between patients who underwent spinal fusion and those who kept the MCGRs in situ.

Patients treated by magnetic growing rods for early-onset scoliosis reach the expected average growth.

Magnetic controlled growing rods (MCGRs)areone of the most common proceduresto treatearly-onset scoliosis(EOS). One of the major concerns is that patients treated with MGCR do not reach an adequateheight with MGCR.The present study has one of the largest samplesizesof EOS patients treated by MGCR.This study aimsto demonstrate theefficacy of the treatmentwith MGCR in EOS patients,comparing our resultswiththeestimatedgrowth. Patients were consecutively enrolled from July 2011 to July 2022.The same surgical equipe performed all the procedures. The mean length of the patients was assessed by X-ray (T2-T12 andT2-S1distance) by a team of expert radiologists.The estimated growth by Dimegliowas compared with themean elongation obtained by year. 65 patients were included.16 patients underwent final surgery.In group 1,patients reached agrowthof 3.6 ± 8.7mm(T2-T12) and 9.6 ± 27.6mm(T2-S1).In group 2,patientsgrew5.4 ± 5.7mm(T2-T12) and 9 ± 9mm(T2-S1).81% of the estimated elongation during the treatment was obtained during the first surgery. The difference betweenDimeglio'sestimated growthand thevalueobtained by MGCR was-4.3 ± 8.7mm(T2-T12) and -12.3 ± 12.2mm(T2-S1)in group 1 (p < 0.001) and -1.1 ± 4.2mm(T2-T12) and -6.6 ± 6.0mm(T2-S1) in group2(p = 0.001). MGCR patients reached andoverlappedthe growth target according to the score by Dimeglio. However, the value of growth tended to reduceoverthe years. Lastly,obtainingthe most significant elongation possible at the first surgeryis mandatory,comprising81% of the total value.

Health-related quality of life and clinical outcomes for magnetically controlled growing rod patients after treatment termination.

To determine the health-related quality of life (HRQoL) and clinical outcomes of children with early onset scoliosis (EOS) treated with magnetically controlled growing rods (MCGR) followed to definitive fusion (DF). A retrospective review of EOS patients treated with MCGR and followed to DF was performed. Outcomes included HRQoL scores, radiographic, clinical, and unplanned returns to the operating room (UPROR) data collected at pre-MCGR implantation, immediately post-MCGR implantation, pre-DF, and post-DF. HRQoL scores were collected at least 6months post-DF. Twenty-eight patients (57.1% females, mean age at MCGR insertion 7.19 ± 1.5years, mean pre-MCGR Cobb 64.7° ± 17.6) met inclusion criteria. MCGR treatment resulted in an overall 30.2% improvement in coronal plane deformity following DF. The mean growth rates between MCGR implantation and pre-DF for T1-T12 height and T1-S1 length were 0.33 ± 0.23mm/month and 0.49 ± 0.28mm/month, respectively. Of the 28 included patients, 26 (92.9%) experienced at least one UPROR, with a total of 52 surgical complications occurring in the total cohort, representing 1.9 UPROR/patient. Interestingly, there was a decline in scores reported between post-MCGR implantation and the pre-DF time-point (N = 16, 78.2 ± 14.9 vs 69.7 ± 17.8, p = 0.02). These scores recovered post-DF, resulting in an overall unchanged HRQoL when comparing pre-MCGR to post-DF (N = 11, 79.9 ± 15.1 vs 76.7 ± 17.9, p = 0.44). While MCGR treatment achieves coronal plane deformity control and facilitates spinal growth, only 7.1% of children experienced a complication-free treatment course when followed to definitive fusion. Patients achieved modest curve correction and spinal growth, while maintaining stable HRQoL outcomes between pre-MCGR and post-DF.

Failure to lengthen consensus for the magnetically controlled growing rod (MCGR).

MCGR lengthening has become an important innovation in treating patients with EOS. An alternative to traditional growing instrumentation, a single surgical procedure is necessary for insertion of the construct, followed by non-invasive lengthening in the outpatient setting. With every new technology emanates a new complication to troubleshoot. Failure to lengthen in the MCGR is a significant cause of revision surgery. Currently, no consensus exists on how to define a MCGR lengthening failure, what steps are necessary after a failure to lengthen, and what factors determine these next steps. The primary goal of this study was to establish a consensus on how to define and navigate a MCGR that fails to lengthen. A series of 3 surveys were distributed to 49 early onset scoliosis surgeons with 37 responses between December 2021 and April 2022. Consensus was defined as at least 70% agreement. 37 of 49 surgeons (75%) responded to the first survey, and all 37 surgeons responded to the following two surveys (100%). Consensus statements were reached on 25% of questions (3/12) from survey 1, 40% of questions (4/10) on survey 2, and 100% of questions (5/5) on survey 3. The questions that reached consensus are detailed in Table 1. Consensus steps to navigate a rod that fails to lengthen 1mm (97%) in the office include retrying during the same visit (78%), changing technique in the office (88%), and not adjusting the interval between lengthening appointments (78%). Table 1 Items that reached consensus from each survey (12 total) Survey Question Response, Consensus Percentage 1 If a rod does not lengthen, do you try again in that office visit?​ Yes, 78% 1 All modes of XR are equivalent when determining failure to lengthen? Yes, 70% 1 If you are unsuccessful at lengthening, you should change the lengthening interval? No, 78% 2 Re-lengthening a rod following a failure to lengthen one should change their technique? Yes, 88% Reposition patient, 100% Alternate rods, 90% No traction in OR, 92.6% 2 Is a MCGR non-operational following 3 consecutive visits where the rod failed lengthening? Yes, 100% 2 Considerations when determining next steps with a non-operational rod? Skeletal Age, 100% Curve Progression, 97% Curve Stiffness, 93.8% Family Convenience, 83% Chronologic Age, 77% Time from Last Lengthening, 70% 2 Can an APP follow your protocol for a rod that has failed to lengthen? Yes, 81% 3 Are you comfortable using either clunk or stall to describe the phenomena of the internal clutch failing within the actuator when lengthening? Yes, 97.3% 3 Clunk/stall try again before an adjustment? Yes, 81% 3 Define failure to lengthen? Less than 1mm length achieved, 97% 3 After two failure to lengthen events do you discuss next surgical steps?​ Yes, 97% 3 Once a rod had been classified as non-operational (no longer lengthening despite interventions) do you consider the underlying diagnosis when making next step decisions? Yes, 97% CONCLUSION: Best clinical practice guidelines using a Delphi method established a consensus on defining failure to lengthen in a MCGR (less than 1mm), appropriate responses to failure to lengthen (re-attempt to lengthen and re-position patient) and a definition for a non-functional MCGR (failure to lengthen 3 consecutive times). This consensus will help standardize research on this important problem. V-expert opinion.

Safety and efficacy of growth-friendly instrumentation for early-onset scoliosis in patients with spinal muscular atrophy type 1 in the disease-modifying treatment era.

To evaluate the safety of growth-friendly instrumentation for early-onset scoliosis (EOS) in patients with spinal muscular atrophy (SMA) type 1 who received disease-modifying treatment (DMT) and analyze short-term efficacy. Retrospective search was conducted between 2017 and 2023. Patients with genetically confirmed SMA type 1 who were surgically treated for spinal deformity and receiving DMTs (nusinersen, risdiplam, or onasemnogene abeparvovec) were included. SMA types 2 and 3 and patients who do not receive DMTs were excluded. Clinical and radiographic data were collected at preoperative, postoperative, and latest follow-up visits. Twenty-eight patients (mean follow-up: 16 months (range 2-41)) were included. The mean age at surgery was 60 months (range 29-96). Fifteen were treated with dual magnetically controlled growing rods (MCGR), four with unilateral MCGR and a contralateral guided growth system, three with Vertical Expandable Prosthetic Titanium Rib (VEPTR®) implants, five with self-distracting systems, and one with traditional dual growing rods. The mean amount of correction was 57% (44°± 17) for scoliosis and 83% (13°± 11) for pelvic obliquity. The mean T1-12 height gain during surgery was 31 mm (±16 mm), while the mean T1 S1 height gain was 51 mm (±24 mm), and instrumented growth was observed during follow-up. Five patients (18%) developed six serious adverse events: three surgical site infections, two anchor failures, and one rod fracture, and all required unplanned reoperations. No neurologic complication, difficulty during nusinersen injections, or respiratory decline was recorded. We report that spinal deformity in this population can be safely treated with growth-friendly instrumentation, with similar complication rates when compared with SMA type 2.