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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


The Bone & Joint Journal
Vol. 95-B, Issue 4 | Pages 543 - 547
1 Apr 2013
Qi M Chen H Liu Y Zhang Y Liang L Yuan W

In a retrospective cohort study we compared the clinical outcome and complications, including dysphagia, following anterior cervical fusion for the treatment of cervical spondylosis using either a zero-profile (Zero-P; Synthes) implant or an anterior cervical plate and cage. A total of 83 patients underwent fusion using a Zero-P and 107 patients underwent fusion using a plate and cage. The mean follow-up was 18.6 months (sd 4.2) in the Zero-P group and 19.3 months (sd 4.1) in the plate and cage group. All patients in both groups had significant symptomatic and neurological improvement. There were no significant differences between the groups in the Neck Disability Index (NDI) and visual analogue scores at final follow-up. The cervical alignment improved in both groups. There was a higher incidence of dysphagia in the plate and cage group on the day after surgery and at two months post-operatively. All patients achieved fusion and no graft migration or nonunion was observed.

When compared with the traditional anterior cervical plate and cage, the Zero-P implant is a safe and convenient procedure giving good results in patients with symptomatic cervical spondylosis with a reduced incidence of dysphagia post-operatively.

Cite this article: Bone Joint J 2013;95-B:543–7.


The Bone & Joint Journal
Vol. 100-B, Issue 4 | Pages 507 - 515
1 Apr 2018
Nnadi C Thakar C Wilson-MacDonald J Milner P Rao A Mayers D Fairbank J Subramanian T

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


Bone & Joint Open
Vol. 5, Issue 9 | Pages 809 - 817
27 Sep 2024
Altorfer FCS Kelly MJ Avrumova F Burkhard MD Sneag DB Chazen JL Tan ET Lebl DR

Aims

To report the development of the technique for minimally invasive lumbar decompression using robotic-assisted navigation.

Methods

Robotic planning software was used to map out bone removal for a laminar decompression after registration of CT scan images of one cadaveric specimen. A specialized acorn-shaped bone removal robotic drill was used to complete a robotic lumbar laminectomy. Post-procedure advanced imaging was obtained to compare actual bony decompression to the surgical plan. After confirming accuracy of the technique, a minimally invasive robotic-assisted laminectomy was performed on one 72-year-old female patient with lumbar spinal stenosis. Postoperative advanced imaging was obtained to confirm the decompression.


Bone & Joint Open
Vol. 4, Issue 8 | Pages 573 - 579
8 Aug 2023
Beresford-Cleary NJA Silman A Thakar C Gardner A Harding I Cooper C Cook J Rothenfluh DA

Aims

Symptomatic spinal stenosis is a very common problem, and decompression surgery has been shown to be superior to nonoperative treatment in selected patient groups. However, performing an instrumented fusion in addition to decompression may avoid revision and improve outcomes. The aim of the SpInOuT feasibility study was to establish whether a definitive randomized controlled trial (RCT) that accounted for the spectrum of pathology contributing to spinal stenosis, including pelvic incidence-lumbar lordosis (PI-LL) mismatch and mobile spondylolisthesis, could be conducted.

Methods

As part of the SpInOuT-F study, a pilot randomized trial was carried out across five NHS hospitals. Patients were randomized to either spinal decompression alone or spinal decompression plus instrumented fusion. Patient-reported outcome measures were collected at baseline and three months. The intended sample size was 60 patients.


Bone & Joint Open
Vol. 5, Issue 3 | Pages 243 - 251
25 Mar 2024
Wan HS Wong DLL To CS Meng N Zhang T Cheung JPY

Aims

This systematic review aims to identify 3D predictors derived from biplanar reconstruction, and to describe current methods for improving curve prediction in patients with mild adolescent idiopathic scoliosis.

Methods

A comprehensive search was conducted by three independent investigators on MEDLINE, PubMed, Web of Science, and Cochrane Library. Search terms included “adolescent idiopathic scoliosis”,“3D”, and “progression”. The inclusion and exclusion criteria were carefully defined to include clinical studies. Risk of bias was assessed with the Quality in Prognostic Studies tool (QUIPS) and Appraisal tool for Cross-Sectional Studies (AXIS), and level of evidence for each predictor was rated with the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach. In all, 915 publications were identified, with 377 articles subjected to full-text screening; overall, 31 articles were included.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1342 - 1347
1 Nov 2024
Onafowokan OO Jankowski PP Das A Lafage R Smith JS Shaffrey CI Lafage V Passias PG

Aims

The aim of this study was to investigate the impact of the level of upper instrumented vertebra (UIV) in frail patients undergoing surgery for adult spine deformity (ASD).

Methods

Patients with adult spinal deformity who had undergone T9-to-pelvis fusion were stratified using the ASD-Modified Frailty Index into not frail, frail, and severely frail categories. ASD was defined as at least one of: scoliosis ≥ 20°, sagittal vertical axis (SVA) ≥ 5 cm, or pelvic tilt ≥ 25°. Means comparisons tests were used to assess differences between both groups. Logistic regression analyses were used to analyze associations between frailty categories, UIV, and outcomes.


Bone & Joint Open
Vol. 4, Issue 11 | Pages 873 - 880
17 Nov 2023
Swaby L Perry DC Walker K Hind D Mills A Jayasuriya R Totton N Desoysa L Chatters R Young B Sherratt F Latimer N Keetharuth A Kenison L Walters S Gardner A Ahuja S Campbell L Greenwood S Cole A

Aims

Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS).

Methods

UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination.


The Bone & Joint Journal
Vol. 105-B, Issue 5 | Pages 543 - 550
1 May 2023
Abel F Avrumova F Goldman SN Abjornson C Lebl DR

Aims

The aim of this study was to assess the accuracy of pedicle screw placement, as well as intraoperative factors, radiation exposure, and complication rates in adult patients with degenerative disorders of the thoracic and lumbar spines who have undergone robotic-navigated spinal surgery using a contemporary system.

Methods

The authors reviewed the prospectively collected data on 196 adult patients who had pedicle screws implanted with robot-navigated assistance (RNA) using the Mazor X Stealth system between June 2019 and March 2022. Pedicle screws were implanted by one experienced spinal surgeon after completion of a learning period. The accuracy of pedicle screw placement was determined using intraoperative 3D fluoroscopy.


Bone & Joint Open
Vol. 3, Issue 5 | Pages 348 - 358
1 May 2022
Stokes S Drozda M Lee C

This review provides a concise outline of the advances made in the care of patients and to the quality of life after a traumatic spinal cord injury (SCI) over the last century. Despite these improvements reversal of the neurological injury is not yet possible. Instead, current treatment is limited to providing symptomatic relief, avoiding secondary insults and preventing additional sequelae. However, with an ever-advancing technology and deeper understanding of the damaged spinal cord, this appears increasingly conceivable. A brief synopsis of the most prominent challenges facing both clinicians and research scientists in developing functional treatments for a progressively complex injury are presented. Moreover, the multiple mechanisms by which damage propagates many months after the original injury requires a multifaceted approach to ameliorate the human spinal cord. We discuss potential methods to protect the spinal cord from damage, and to manipulate the inherent inhibition of the spinal cord to regeneration and repair. Although acute and chronic SCI share common final pathways resulting in cell death and neurological deficits, the underlying putative mechanisms of chronic SCI and the treatments are not covered in this review.


The Bone & Joint Journal
Vol. 104-B, Issue 2 | Pages 257 - 264
1 Feb 2022
Tahir M Mehta D Sandhu C Jones M Gardner A Mehta JS

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).

Methods

We undertook a retrospective review of skeletally mature patients who had undergone fusion for an EOS, which had been previously treated using either TGRs or MCGRs. Measured outcomes included sequential coronal T1 to S1 height and major curve (Cobb) angle on plain radiographs and any complications requiring unplanned surgery before final fusion.


The Bone & Joint Journal
Vol. 100-B, Issue 9 | Pages 1187 - 1200
1 Sep 2018
Subramanian T Ahmad A Mardare DM Kieser DC Mayers D Nnadi C

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. Patients and Methods. An observational study of 31 consecutive children with EOS, of whom 15 were male, who were treated between December 2011 and October 2017 was undertaken. Their mean age was 7.7 years (2 to 14). The mean follow-up was 47 months (24 to 69). Distractions were completed using the tailgating technique. The primary outcome measure was correction of the radiographic deformity. Secondary outcomes were growth, functional outcomes and complication rates. Results. The mean Cobb angle was 54° (14° to 91°) preoperatively and 37° (11° to 69°) at the latest follow-up (p < 0.001). The mean thoracic kyphosis (TK) was 45° (10° to 89°) preoperatively and 42° (9° to 84°) at the latest follow-up. The mean T1–S1 height increased from 287 mm (209 to 378) to 338 mm (240 to 427) (p < 0.001) and the mean sagittal balance reduced from 68 mm (-76 to 1470) preoperatively to 18 mm (-32 to 166) at the latest follow-up. The mean coronal balance was 3 mm (-336 to 64) preoperatively and 8 mm (-144 to 64) at the latest follow-up. The mean increase in weight and sitting and standing height at the latest follow-up was 45%, 10% and 15%, respectively. The mean Activity Scale for Kids (ASKp) scores increased in all domains, with only personal care and standing skills being significant at the latest follow-up (p = 0.02, p = 0.03). The improvements in Cobb angle, TK and T1-S1 heights were not related to gender, the aetiology of the EOS, or whether the procedure was primary or conversion from a conventional growing rod system. A total of 21 children developed 23 complications at a rate of 0.23 per patient per year. Seven developed MCGR-specific complications. Complications developed at a mean of 38 months (3 to 67) after the initial surgery and required 22 further procedures. Children who developed a complication were more likely to be younger, have syndromic EOS, and have a single-rod construct (6.9 versus 9.3 years, p = 0.034). Conclusion. The progression of EOS can be controlled using MCGRs allowing growth and improved function. Younger and syndromic children are more likely to develop complications following surgery. Cite this article: Bone Joint J 2018;100-B:1187–1200


Bone & Joint Research
Vol. 7, Issue 2 | Pages 124 - 130
1 Feb 2018
Coric D Bullard DE Patel VV Ryaby JT Atkinson BL He D Guyer RD

Objectives. Pulsed electromagnetic field (PEMF) stimulation was evaluated after anterior cervical discectomy and fusion (ACDF) procedures in a randomized, controlled clinical study performed for United States Food and Drug Administration (FDA) approval. PEMF significantly increased fusion rates at six months, but 12-month fusion outcomes for subjects at elevated risk for pseudoarthrosis were not thoroughly reported. The objective of the current study was to evaluate the effect of PEMF treatment on subjects at increased risk for pseudoarthrosis after ACDF procedures. Methods. Two evaluations were performed that compared fusion rates between PEMF stimulation and a historical control (160 subjects) from the FDA investigational device exemption (IDE) study: a post hoc (PH) analysis of high-risk subjects from the FDA study (PH PEMF); and a multicentre, open-label (OL) study consisting of 274 subjects treated with PEMF (OL PEMF). Fisher’s exact test and multivariate logistic regression was used to compare fusion rates between PEMF-treated subjects and historical controls. Results. In separate comparisons of PH PEMF and OL PEMF groups to the historical control group, PEMF treatment significantly (p < 0.05, Fisher’s exact test) increased the fusion rate at six and 12 months for certain high-risk subjects who had at least one clinical risk factor of being elderly, a nicotine user, osteoporotic, or diabetic; and for those with at least one clinical risk factor and who received at least a two- or three-level arthrodesis. Conclusion. Adjunctive PEMF treatment can be recommended for patients who are at high risk for pseudoarthrosis. Cite this article: D. Coric, D. E. Bullard, V. V. Patel, J. T. Ryaby, B. L. Atkinson, D. He, R. D. Guyer. Pulsed electromagnetic field stimulation may improve fusion rates in cervical arthrodesis in high-risk populations. Bone Joint Res 2018;7:124–130. DOI: 10.1302/2046-3758.72.BJR-2017-0221.R1


Bone & Joint Research
Vol. 10, Issue 12 | Pages 797 - 806
8 Dec 2021
Chevalier Y Matsuura M Krüger S Traxler H Fleege† C Rauschmann M Schilling C

Aims

Anchorage of pedicle screw rod instrumentation in the elderly spine with poor bone quality remains challenging. Our study aims to evaluate how the screw bone anchorage is affected by screw design, bone quality, loading conditions, and cementing techniques.

Methods

Micro-finite element (µFE) models were created from micro-CT (μCT) scans of vertebrae implanted with two types of pedicle screws (L: Ennovate and R: S4). Simulations were conducted for a 10 mm radius region of interest (ROI) around each screw and for a full vertebra (FV) where different cementing scenarios were simulated around the screw tips. Stiffness was calculated in pull-out and anterior bending loads.


The Bone & Joint Journal
Vol. 99-B, Issue 12 | Pages 1658 - 1664
1 Dec 2017
Ahmad A Subramanian T Panteliadis P Wilson-Macdonald J Rothenfluh DA Nnadi C

Aims. Magnetically controlled growing rods (MCGRs) allow non-invasive correction of the spinal deformity in the treatment of early-onset scoliosis. Conventional growing rod systems (CGRS) need repeated surgical distractions: these are associated with the effect of the ‘law of diminishing returns’. The primary aim of this study was to quantify this effect in MCGRs over sequential distractions. . Patients and Methods. A total of 35 patients with a maximum follow-up of 57 months were included in the study. There were 17 boys and 18 girls with a mean age of 7.4 years (2 to 14). True Distraction (TD) was determined by measuring the expansion gap on fluoroscopy. This was compared with Intended Distraction (ID) and expressed as the ‘T/I’ ratio. The T/I ratio and the Cobb angle were calculated at several time points during follow-up. Results. The mean follow-up was 30 months (6 to 57). There was a significant decrease in the mean T/I ratio over time (convex rod at 3 months 0.81, . sd. 0.58 vs 51 months 0.17, . sd . 0.16, p = 0.0001; concave rod at 3 months 0.93, . sd. 0.67 vs 51 months 0.18, . sd. 0.15, p = 0.0001). A linear decline of the mean T/I ratios was noted for both convex rods (r. 2. = 0.90, p = 0.004) and concave rods (r. 2. = 0.81, p = 0.015) over 51 months. At the 24-month follow-up stage, there was a significant negative correlation between the mean T/I ratio of the concave rod with weight (r = -0.59, p = 0.01), age (r = -0.59, p = 0.01), and BMI of the child (r = -0.54, p = 0.01). Conclusions. The ‘law of diminishing returns’ is also seen after serial distraction using MCGR. Compared to previously published data for CGRS, there is a gradual linear decline rather than a rapid initial decline in lengthening. In older, heavier children a reduced distraction ratio in the concave rod of the MCGR device is noted over time. Cite this article: Bone Joint J 2017;99-B:1658–64


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 373 - 381
1 Feb 2021
Strube P Gunold M Müller T Leimert M Sachse A Pumberger M Putzier M Zippelius T

Aims

The aim of the present study was to answer the question whether curve morphology and location have an influence on rigid conservative treatment in patients with adolescent idiopathic scoliosis (AIS).

Methods

We retrospectively analyzed AIS in 127 patients with single and double curves who had been treated with a Chêneau brace and physiotherapeutic specific exercises (B-PSE). The inclusion criteria were the presence of structural major curves ≥ 20° and < 50° (Risser stage 0 to 2) at the time when B-PSE was initiated. The patients were divided into two groups according to the outcome of treatment: failure (curve progression to ≥ 45° or surgery) and success (curve progression < 45° and no surgery). The main curve type (MCT), curve magnitude, and length (overall, above and below the apex), apical rotation, initial curve correction, flexibility, and derotation by the brace were compared between the two groups.


The Bone & Joint Journal
Vol. 96-B, Issue 6 | Pages 807 - 816
1 Jun 2014
Rajaee SS Kanim LEA Bae HW

Using the United States Nationwide Inpatient Sample, we identified national trends in revision spinal fusion along with a comprehensive comparison of comorbidities, inpatient complications and surgical factors of revision spinal fusion compared to primary spinal fusion. In 2009, there were 410 158 primary spinal fusion discharges and 22 128 revision spinal fusion discharges. Between 2002 and 2009, primary fusion increased at a higher rate compared with revision fusion (56.4% vs 51.0%; p < 0.001). In 2009, the mean length of stay and hospital charges were higher for revision fusion discharges than for primary fusion discharges (4.2 days vs 3.8 days, p < 0.001; USD $91 909 vs. $87 161, p < 0.001). In 2009, recombinant human bone morphogenetic protein (BMP) was used more in revision fusion than in primary fusion (39.6% vs 27.6%, p < 0.001), whereas interbody devices were used less in revision fusion (41.8% vs 56.6%, p < 0.001). . In the multivariable logistic regression model for all spinal fusions, depression (odds ratio (OR) 1.53, p < 0.001), psychotic disorders (OR 1.49, p < 0.001), deficiency anaemias (OR 1.35, p < 0.001) and smoking (OR 1.10, p = 0.006) had a greater chance of occurrence in revision spinal fusion discharges than in primary fusion discharges, adjusting for other variables. In terms of complications, after adjusting for all significant comorbidities, this study found that dural tears (OR 1.41; p < 0.001) and surgical site infections (OR 3.40; p < 0.001) had a greater chance of occurrence in revision spinal fusion discharges than in primary fusion discharges (p < 0.001). A p-value < 0.01 was considered significant in all final analyses. Cite this article: Bone Joint J 2014;96-B:807–16


Bone & Joint Open
Vol. 2, Issue 3 | Pages 163 - 173
1 Mar 2021
Schlösser TPC Garrido E Tsirikos AI McMaster MJ

Aims

High-grade dysplastic spondylolisthesis is a disabling disorder for which many different operative techniques have been described. The aim of this study is to evaluate Scoliosis Research Society 22-item (SRS-22r) scores, global balance, and regional spino-pelvic alignment from two to 25 years after surgery for high-grade dysplastic spondylolisthesis using an all-posterior partial reduction, transfixation technique.

Methods

SRS-22r and full-spine lateral radiographs were collected for the 28 young patients (age 13.4 years (SD 2.6) who underwent surgery for high-grade dysplastic spondylolisthesis in our centre (Scottish National Spinal Deformity Service) between 1995 and 2018. The mean follow-up was nine years (2 to 25), and one patient was lost to follow-up. The standard surgical technique was an all-posterior, partial reduction, and S1 to L5 transfixation screw technique without direct decompression. Parameters for segmental (slip percentage, Dubousset’s lumbosacral angle) and regional alignment (pelvic tilt, sacral slope, L5 incidence, lumbar lordosis, and thoracic kyphosis) and global balance (T1 spino-pelvic inclination) were measured. SRS-22r scores were compared between patients with a balanced and unbalanced pelvis at final follow-up.


Bone & Joint Research
Vol. 9, Issue 10 | Pages 653 - 666
7 Oct 2020
Li W Li G Chen W Cong L

Aims

The aim of this study was to systematically compare the safety and accuracy of robot-assisted (RA) technique with conventional freehand with/without fluoroscopy-assisted (CT) pedicle screw insertion for spine disease.

Methods

A systematic search was performed on PubMed, EMBASE, the Cochrane Library, MEDLINE, China National Knowledge Infrastructure (CNKI), and WANFANG for randomized controlled trials (RCTs) that investigated the safety and accuracy of RA compared with conventional freehand with/without fluoroscopy-assisted pedicle screw insertion for spine disease from 2012 to 2019. This meta-analysis used Mantel-Haenszel or inverse variance method with mixed-effects model for heterogeneity, calculating the odds ratio (OR), mean difference (MD), standardized mean difference (SMD), and 95% confidence intervals (CIs). The results of heterogeneity, subgroup analysis, and risk of bias were analyzed.


The Bone & Joint Journal
Vol. 102-B, Issue 12 | Pages 1703 - 1708
1 Dec 2020
Miyanji F Pawelek J Nasto LA Simmonds A Parent S

Aims

Spinal fusion remains the gold standard in the treatment of idiopathic scoliosis. However, anterior vertebral body tethering (AVBT) is gaining widespread interest, despite the limited data on its efficacy. The aim of our study was to determine the clinical efficacy of AVBT in skeletally immature patients with idiopathic scoliosis.

Methods

All consecutive skeletally immature patients with idiopathic scoliosis treated with AVBT enrolled in a longitudinal, multicentre, prospective database between 2013 and 2016 were analyzed. All patients were treated by one of two surgeons working at two independent centres. Data were collected prospectively in a multicentre database and supplemented retrospectively where necessary. Patients with a minimum follow-up of two years were included in the analysis. Clinical success was set a priori as a major coronal Cobb angle of < 35° at the most recent follow-up.