Surgical treatment of neuromuscular Early Onset Scoliosis with a bilateral posterior one-way rod compared to the Spring Distraction System: study protocol for a limited-efficacy Randomized Controlled Trial (BiPOWR).

BACKGROUND: Early Onset Scoliosis (EOS) is a progressive spinal deformity in children, and a potentially life-threatening disease. "Growth-friendly" surgical techniques aim to control the deformity, while allowing the spine and trunk to maintain growth. Current "growth-friendly" systems such as the traditional growing rod (TGR) and magnetically controlled growing rod (MCGR) have limitations that reduce their efficacy and cost-effectiveness. Recently, two "growth-friendly" systems have been developed that mitigate many of these limitations, the Spring Distraction System (SDS) and the One Way Self-Expanding Rod (OWSER). The purpose of the multicenter BiPOWR trial is to investigate, describe and compare the 1-year limited-efficacy and -safety of both strategies in the treatment of neuromuscular EOS. METHODS: After informed consent, 28 neuromuscular EOS patients will be randomized to receive either the SDS or the OWSER. Patients and caregivers will be blinded to allocation until after surgery. Primary outcomes will be maintenance of coronal curve correction and the occurrence of serious adverse events. In addition, spinal growth, implant lengthening, and perioperative findings are recorded systematically. At each follow-up moment, the Early Onset Scoliosis Questionnaire (EOSQ-24) will be used to assess health-related quality of life. All outcomes will be compared between groups. DISCUSSION: The BiPOWR trial is the first randomized controlled trial that compares two specific "growth-friendly" implants in a specified EOS population. It will determine the 1-year limited-efficacy and safety of the SDS and OWSER implants. TRIAL REGISTRATION: Clinicaltrials.gov: NCT04021784 (13-06-2019). CCMO registry: NL64018.041.17 (06-05-2019).

Methodological aspects of a randomized within-patient concurrent controlled design for clinical trials in spine surgery.

INTRODUCTION: Randomized controlled trials are considered the highest level of evidence, but their feasibility in the surgical field is severely hampered by methodological and practical issues. Concurrent comparison between the experimental and control conditions within the same patient can be an effective strategy to mitigate some of these challenges and improve generalizability, mainly by the elimination of between-patient variability and reduction of the required sample size. This article aims (1) to describe the methodological aspects of a randomized within-patient controlled trial and (2) to quantify the added value of this design, based on a recently completed randomized within-patient controlled trial on bone grafts in instrumented lumbar posterolateral spinal fusion. METHODS: Boundary conditions for the application of the randomized within-patient controlled trial design were identified. Between-patient variability was quantified by the intraclass correlation coefficient and concordance in the primary fusion outcome. Sample size, study duration and costs were compared with a classic randomized controlled trial design. RESULTS: Boundary conditions include the concurrent application of the experimental and control conditions to identical but physically separated sites. Moreover, the outcome of interest should be local, uncorrelated and independently assessable. The spinal fusion outcomes within a patient were found to be more similar than between different patients (intraclass correlation coefficient 32% and concordance 64%), demonstrating a clear effect of patient-related factors. The randomized within-patient controlled trial design allowed a reduction of the sample size to one-third of a parallel-group randomized controlled trial, thereby halving the trial duration and costs. CONCLUSION: When suitable, the randomized within-patient controlled trial is an efficient design that provides a solution to some of the considerable challenges of a classic randomized controlled trial in (spine) surgery. This design holds specific promise for efficacy studies of non-active bone grafts in instrumented posterolateral fusion surgery.

The potential of spring distraction to dynamically correct complex spinal deformities in the growing child.

PURPOSE: Current treatment of progressive early onset scoliosis involves growth-friendly instrumentation if conservative treatment fails. These implants guide growth by passive sliding or repeated lengthenings. None of these techniques provide dynamic correction after implantation. We developed the spring distraction system (SDS), by using one or multiple compressed springs positioned around a standard sliding rod, to provide active continuous distraction of the spine to stimulate growth and further correction. The purpose of this study was to determine feasibility and proof of concept of the SDS. METHODS: We developed a versatile, dynamic spring distraction system for patients who would benefit from active continuous distraction. This prospective case series evaluates four patients with exceptional and progressive congenital spine deformities. RESULTS: Four patients had a mean age of 6.8 years at surgery with a mean follow-up of 36 months (range 25-45). The mean progressive thoracic lordosis, which was the reason for initiating surgical treatment in two patients, changed from 32° lordosis preoperatively to 1° kyphosis post-operatively. During follow-up, this further improved to 32° thoracic kyphosis. In the two other patients, with cervicothorcacic scoliosis, the main coronal curve improved from 79° pre-operatively to 56° post-operatively and further improved to 42°. The mean T1-S1 spine growth during follow-up for all patients was 1.3 cm/year. There was one reoperation because of skin problems and no device-failures. CONCLUSION: These early results show the feasibility and the proof of concept of spring-based distraction as a dynamic growth-enhancing system with the potential of further correction of the deformity after implantation.

The role of sagittal pelvic morphology in the development of adult degenerative scoliosis.

PURPOSE: Pelvic morphology dictates the alignment and biomechanics of the spine. Recent observations in different types of adolescent idiopathic scoliosis indicate that individual pelvic morphology is related to the spinal levels in which scoliosis develops: primary lumbar adolescent scoliosis is associated with a higher pelvic incidence (PI) than thoracic scoliosis and non-scoliotic controls. We hypothesize that adult degenerative scoliosis (ADS) of the lumbar spine follows the same mechanical principles and is associated with a high PI. METHODS: This study used an existing CT-scan database, 101 ADS patients were sex and age matched to 101 controls. The PI was measured by two observers with multi-planar reconstruction, perpendicular to the hip-axis according to a previously validated technique. RESULTS: The PI was 54.1° ± 10.8° in ADS patients and 47.7° ± 10.8° in non-scoliotic controls (p < 0.001). The median ADS curve apex was the disc L2-3 and median curve length was 4 vertebral levels. The mean supine Cobb angle was 21° ± 8° (ranged 10°-47°). There was no significant correlation between PI and the apex level (p = 0.883), the curve length (p = 0.418) or the Cobb angle (p = 0.518). CONCLUSIONS: ADS normally develops de novo in the lumbar spine of patients with a higher PI than controls, similar to primary lumbar adolescent idiopathic scoliosis. This suggests a shared mechanical basis of both deformities. Pelvic morphology dictates spinal sagittal alignment, which determines the segments of the spine that are prone to develop scoliosis.

Changes in the Position of the Junctional Vertebrae After Posterior Spinal Fusion in Adolescent Idiopathic Scoliosis: Implication in Risk Assessment of Proximal Junctional Kyphosis Development.

BACKGROUND: The development of proximal junctional kyphosis (PJK) after posterior spinal fusion in adolescent idiopathic scoliosis is a major problem. Changes in the global sagittal parameters as they relate to PJK have been reported after surgery, however, the relationships between the changes in the upper-instrumented vertebra (UIV) during and after surgery as they relate to development of PJK have not been quantified. We hypothesize that the compensatory changes in the unfused segments of the spine over time are correlated with the surgically induced changes in the UIV position. METHODS: Sixty adolescent idiopathic scoliosis patients (with at least 1-year follow-up) who underwent posterior spinal surgery were included retrospectively. Global spinal parameters were calculated using 3-dimensional models of the spine, additional parameters [proximal junctional kyphosis angle (PJKA), cervical lordosis angle] were measured manually before surgery and at 3 postoperative follow-ups. The 3-dimensional position of the vertebral body centroids was calculated for T1, UIV, and lower-instrumented vertebra at all timepoints. The sagittal position of T1, UIV, and lower-instrumented vertebra were correlated to the cervical lordosis, PJKA, lumbar lordosis, and pelvic tilt. RESULTS: The position of T1 and UIV were significantly more anterior at first erect for patients who developed PJK. The posterior shift of UIV at the most recent follow-up as compared with the preoperative position was significant in both the PJK and non-PJK cohort. A larger anterior shift in UIV at first erect correlated with a larger T1 and UIV posterior shift at the most recent follow-up. At the most recent follow-up, a more posterior position of the UIV correlated with a larger angle of PJKA (P<0.05). CONCLUSION: Both a larger anterior shift of UIV between preoperative and first erect and a more posterior position of UIV at the most recent follow-up was correlated with a higher PJKA. A larger anterior shift in the position of the UIV after surgery was associated with a higher posterior shift of UIV at the last follow-up. The surgically induced changes in the UIV are an important parameter associated with the development of PJK. LEVEL OF EVIDENCE: Level IV.

The diagnostic accuracy of 18F-FDG PET/CT in diagnosing fracture-related infections.

PURPOSE: 18F-Fluorodeoxyglucose positron emission tomography (18F-FDG PET/CT) is frequently used to diagnose fracture-related infections (FRIs), but its diagnostic performance in this field is still unknown. The aims of this study were: (1) to assess the diagnostic performance of qualitative assessment of 18F-FDG PET/CT scans in diagnosing FRI, (2) to establish the diagnostic performance of standardized uptake values (SUVs) extracted from 18F-FDG PET/CT scans and to determine their associated optimal cut-off values, and (3) to identify variables that predict a false-positive (FP) or false-negative (FN) 18F-FDG PET/CT result. METHODS: This retrospective cohort study included all patients with suspected FRI undergoing 18F-FDG PET/CT between 2011 and 2017 in two level-1 trauma centres. Two nuclear medicine physicians independently reassessed all 18F-FDG PET/CT scans. The reference standard consisted of the result of at least two deep, representative microbiological cultures or the presence/absence of clinical confirmatory signs of FRI (AO/EBJIS consensus definition) during a follow-up of at least 6 months. Diagnostic performance in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) was calculated. Additionally, SUVs were measured on 18F-FDG PET/CT scans. Volumes of interest were drawn around the suspected and corresponding contralateral areas to obtain absolute values and ratios between suspected and contralateral areas. A multivariable logistic regression analysis was also performed to identify the most important predictor(s) of FP or FN 18F-FDG PET/CT results. RESULTS: The study included 156 18F-FDG PET/CT scans in 135 patients. Qualitative assessment of 18F-FDG PET/CT scans showed a sensitivity of 0.89, specificity of 0.80, PPV of 0.74, NPV of 0.91 and diagnostic accuracy of 0.83. SUVs on their own resulted in lower diagnostic performance, but combining them with qualitative assessments yielded an AUC of 0.89 compared to an AUC of 0.84 when considering only the qualitative assessment results (p = 0.007). 18F-FDG PET/CT performed <1 month after surgery was found to be the independent variable with the highest predictive value for a false test result, with an absolute risk of 46% (95% CI 27-66%), compared with 7% (95% CI 4-12%) in patients with 18F-FDG PET/CT performed 1-6 months after surgery. CONCLUSION: Qualitative assessment of 18F-FDG PET/CT scans had a diagnostic accuracy of 0.83 and an excellent NPV of 0.91 in diagnosing FRI. Adding SUV measurements to qualitative assessment provided additional accuracy in comparison to qualitative assessment alone. An interval between surgery and 18F-FDG PET/CT of <1 month was associated with a sharp increase in false test results.

Spinal Balance/Alignment - Clinical Relevance and Biomechanics.

In the normal spine due to its curvature in various regions, C7 plumb line (C7PL) passes through the sacrum so that the head is centered over the pelvis-ball and socket hip joints and ankle joints. This configuration leads to the least muscular activities to maintain the spinal balance. For any reason like deformity, scoliosis, kyphosis, trauma, and/or surgery this optimal configuration gets disturbed requiring higher muscular activity to maintain the posture and balance. Several parameters like the thoracic kyphosis (TK), lumbar lordosis (LL), pelvic incidence (PI), sacral slope (SS), Hip- and leg position influence the sagittal balance and thus the optimal configuration of spinal alignment. Global sagittal imbalance is energy consuming and often painful compensatory mechanisms are developed, that in turn negatively influence the quality of life. This review looks at the clinical aspects of spinal imbalance, and the biomechanics of spinal balance as dictated by the deformities- ankylosing spondylitis, scoliosis and kyphosis; surgical corrections- pedicle subtraction osteotomies and long segment stabilizations and consequent postural complications like the proximal and distal junctional kyphosis. This review suggests several potential research topics as well.

Orthopaedic manifestations within the 22q11.2 Deletion syndrome: A systematic review.

The 22q11.2 Deletion Syndrome (22q11.2DS) is the most common microdeletion syndrome with an estimated prevalence of 1:4,000 live births. 22q11.2DS is known to have wide phenotypic variability, including orthopaedic manifestations. The purpose of this systematic review is to increase the awareness of orthopaedic manifestations associated with 22q11.2DS. This systematic review was performed according to the PRISMA Guidelines. Original epidemiological studies on the prevalence of orthopaedic manifestations within 22q11.2DS were systematically searched for in PubMed and EMBASE. The included articles were scored according to a risk-of-bias tool, a best-evidence synthesis was performed and the prevalence data was extracted. Sixty-nine published manuscripts described 58 orthopaedic manifestations in a total of 6,055 patients. The prevalence of at least one cervical or occipital anomaly is 90.5-100% (strong evidence). Fourteen studies (n = 2,264) revealed moderate evidence for a wide scoliosis prevalence of 0.6-60%. Two studies demonstrated that 5-6.4% of all 22q11.2DS patients required surgical scoliosis correction. Fifteen studies (n = 2,115) reported a 1.1-13.3% prevalence of clubfoot with moderate evidence. Other reported orthopaedic manifestations are patellar dislocation (10-20%), juvenile rheumatic arthritis (3.75%), impaired growth and skeletal anomalies like polydactyly (1.0-3.7%), syndactyly (11-11.8%), butterfly vertebrae (11.1%) and 13 ribs (2-19%). Orthopaedic findings are important manifestations of the 22q11.2DS, both in bringing patients to diagnostic attention and in requiring surveillance and appropriate intervention. Data on these manifestations are scattered and incomprehensive. Routinely screening for cervical anomalies, scoliosis, and upper and lower limb malformations is recommended in this vulnerable group of patients.

Chyluria and chylothorax after posterior selective fusion for adolescent idiopathic scoliosis.

PURPOSE: To describe and discuss the diagnostic and treatment complexity of lymphatic system complications after scoliosis surgery. METHODS: Surgery for adolescent idiopathic scoliosis is very commonly performed with posterior pedicle screw instrumentation. Complications of the anteriorly based lymphatic system are, therefore, rare. We present a case with complications related to the lymphatic system, which have not been reported before after this type of surgery. RESULTS: After standard Th3 to Th12 posterior spinal reduction and fusion of a moderate thoracic curve, chyluria and a chylothorax developed in an adolescent girl. This appeared to be caused by an obstruction of the thoracic duct. Thorax drainage and finally thoracoscopic intervention prevented further pulmonal impairment. The exact cause could not be identified and the persistent lymph drainage problems had to be treated with a medium chain triglyceride diet. CONCLUSION: With this report, we aim to create awareness of the lymphatic system in general and the possibility of severe complications, even after a posterior only approach of the vertebral column.

Spinal shape modulation in a porcine model by a highly flexible and extendable non-fusion implant system.

PURPOSE: In vivo evaluation of scoliosis treatment using a novel approach in which two posterior implants are implanted: XSLAT (eXtendable implant correcting Scoliosis in LAT bending) and XSTOR (eXtendable implant correcting Scoliosis in TORsion). The highly flexible and extendable implants use only small, but continuous lateral forces (XSLAT) and torques (XSTOR), thereby allowing growth and preventing fusion. METHODS: Since (idiopathic) scoliosis does not occur spontaneously in animals, the device was used to induce a spinal deformity rather than correct it. Six of each implants were tested for their ability to induce scoliotic deformations in 12 growing pigs. Each implant spanned six segments and was attached to three vertebrae using sliding anchors. Radiological and histological assessments were done throughout the 8-week study. RESULTS: In all animals, the intended deformation was accomplished. Average Cobb angles were 19° for XSLAT and 6° for XSTOR. Average apical spinal torsion was 0° for XSLAT and 9° for XSTOR. All instrumented segments remained mobile and showed 20 % growth. Moderate degeneration of the facet joints was observed and some debris was found in the surrounding tissue. CONCLUSIONS: The approach accomplished the intended spinal deformation while allowing growth and preventing fusion.

Plate fixation or intramedullary fixation for midshaft clavicle fractures: a systematic review and meta-analysis of randomized controlled trials and observational studies.

BACKGROUND: The last decade has shown a shift toward operative treatment of a subset of midshaft clavicle fractures. However, it is unclear whether there are differences between plate fixation and intramedullary fixation regarding complications and functional outcome. The aim of this systematic review and meta-analysis was to compare plate fixation and intramedullary fixation for midshaft clavicle fractures. METHODS: The Medline, Embase, and Cochrane databases were searched for both randomized controlled trials and observational studies. The methodologic quality of all included studies was assessed using the Methodological Index for Non-Randomized Studies. RESULTS: Twenty studies were included. Ten of the 20 included studies used a fracture classification. Seven of these studies reported exclusion of patients with comminuted fractures. No difference in the total re-intervention rate was found (odds ratio [OR], 1.21; 95% confidence interval [CI], 0.71 to 2.04). Major re-interventions occurred more often after plate fixation (OR, 1.88; 95% CI, 1.02 to 3.46). The mean implant removal rates were 38% after plate fixation and 73% after intramedullary fixation. Re-fracture after implant removal occurred more often after plate fixation (OR, 3.42; 95% CI, 1.12 to 10.42). The Constant-Murley scores showed no differences at both short term (mean difference, -1.18; 95% CI, -13.41 to 11.05) and long term (mean difference, 0.15; 95% CI, -1.57 to 1.87). No differences were observed regarding nonunion (OR, 1.50; 95% CI, 0.82 to 2.75). The rate of infections showed no differences when outlier studies were excluded (OR, 1.54; 95% CI, 0.88 to 2.69). CONCLUSION: Major re-intervention and re-fracture after implant removal occurred more frequently after plate fixation of non-comminuted, displaced midshaft clavicle fractures. No differences in terms of function and nonunion between plate fixation and intramedullary fixation were observed.

Comment on Grabala et al. Radiological Outcomes of Magnetically Controlled Growing Rods for the Treatment of Children with Various Etiologies of Early-Onset Scoliosis-A Multicenter Study. J. Clin. Med. 2024, 13, 1529.

We read with great interest the study titled "Radiological Outcomes of Magnetically Controlled Growing Rods for the Treatment of Children with Various Etiologies of Early-Onset Scoliosis-A Multicenter Study" by Grabala and colleagues [...].

Health-related quality of life in early onset scoliosis patients treated with the spring distraction system: what to expect in the first 2 years after surgery.

PURPOSE: The Spring Distraction System (SDS) is a novel "growth-friendly" implant for the treatment of Early-Onset Scoliosis (EOS). This prospective study aims to determine the evolution of the "24-Item Early-Onset Scoliosis Questionnaire" (EOSQ-24) scores during 2-year follow-up after SDS surgery. Secondary aims include investigating the relation between EOSQ-24 scores and EOS etiology, and evaluating the impact of an unplanned return to the operating room (UPROR) on HRQoL. METHODS: All SDS patients with at least 2-year follow-up were included. Caregivers completed the EOSQ-24 pre-operatively, post-operatively, and at 6, 12, and 24 month follow-up. Mean total and -domain scores were graphed over time. Repeated-measures ANOVA analyzed the influence of etiology on EOSQ-24 scores. Multiple regression analyzed associations between UPRORs and EOSQ-24 scores. RESULTS: Forty-nine patients were included. Mean total EOSQ-24 scores decreased from 70 pre-operatively to 66 post-operatively, then gradually increased to 75 (24 months). Most domains exhibited changes over time, with initial declines, but eventually surpassing pre-operative levels after 2-year follow-up. Neuromuscular/Syndromic patients had lower scores, but showed similar improvements over time compared with other etiologies. Multiple regression showed lower Parental Burden domain score (- 14 points) in patients with UPRORs, although no significant reductions were found in total score, or in other domains. CONCLUSION: HRQoL decreases immediately following SDS surgery but quickly recovers and exceeds pre-operative levels at 2-year follow-up in all domains. Neuromuscular/Syndromic patients have lower initial scores, but progress similarly over time. UPRORs do not influence EOSQ-24 scores, except for a negative impact on the Parental Burden domain in the short term. LEVEL OF EVIDENCE: III.

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.

Purpose: 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. Methods: 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. Results: 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. Conclusion: 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.

Maturation of the vertebral ring apophysis is delayed in girls with adolescent idiopathic scoliosis compared to the normal population.

PURPOSE: The ring apophysis is a secondary ossification center on both sides of each vertebral body, to which the annulus of the intervertebral disc inserts. Recently, its pattern of ossification and fusion to the vertebral body was described for the normal growing spine. The aim of the present study was to investigate the ossification and fusion of the ring apophysis in patients with adolescent idiopathic scoliosis (AIS) and compare it to the normal growing population. METHODS: Ring apophysis maturation along the entire thoracic and lumbar spine was analyzed on CT scans of 99 female, pre-operative AIS patients and compared to 134 CT scans of non-scoliotic girls, aged 12 to 20. RESULTS: The ring apophysis maturation in AIS patients was delayed at all spinal levels in AIS patients compared to non-scoliotic controls. Ossification starts at T4-T11 at age 12, followed by T1-T5 and L3-S1 at age 15. The fusion process in AIS patients continues longer in the midthoracic region as compared to the other regions and as compared to non-scoliotic controls, with many incomplete fusions still at age 20. CONCLUSION: The ring apophysis maturation in AIS is delayed compared to that in the normal population and lasts longer in the mid/low thoracic spine. Delayed maturation of the spine's most important stabilizer, while the body's dimensions continue to increase, could be part of the patho-mechanism of AIS.

Efficacy of Biphasic Calcium Phosphate Ceramic With a Needle-shaped Surface Topography Versus Autograft in Instrumented Posterolateral Spinal Fusion: A Randomized Trial.

STUDY DESIGN: A multicenter randomized controlled noninferiority trial with intrapatient comparisons. OBJECTIVE: The aim of this study was to determine noninferiority of a slowly resorbable Biphasic Calcium Phosphate with submicron microporosity (BCP<µm, MagnetOs™ Granules) as an alternative for autograft in instrumented posterolateral fusion (PLF). SUMMARY OF BACKGROUND DATA: Successful spinal fusion with a solid bone bridge between the vertebrae is traditionally achieved by grafting with autologous iliac bone. However, the disadvantages of autograft and unsatisfactory fusion rates have prompted the exploration of alternatives, including ceramics. Nevertheless, clinical evidence for the standalone use of these materials is limited. METHODS: Adults indicated for instrumented PLF (one to six levels) were enrolled at five participating centers. After bilateral instrumentation and fusion-bed preparation, the randomized allocation side (left or right) was disclosed. Per segment 10cc of BCP<µm granules (1-2 mm) was placed in the posterolateral gutter on one side and 10cc autograft on the contralateral side. Fusion was systematically scored on 1-year follow-up CT scans. The study was powered to detect >15% inferiority with binomial paired comparisons of the fusion performance score per treatment side. RESULTS: Of the 100 patients (57 ± 12.9 years, 62% female), 91 subjects and 128 segments were analyzed. The overall posterolateral fusion rate per segment (left and/or right) was 83%. For the BCP<µm side only the fusion rate was 79% vs. 47% for the autograft side (difference 32 percentage points, 95% CI = 23-41). Analysis of the primary outcome confirmed the noninferiority of BCP<µm with an absolute difference in paired proportions of 39.6% (95% CI = 26.8-51.2, < 0.001). CONCLUSION: This clinical trial demonstrates noninferiority and suggest several attractive features of MagnetOs™ Granules as a standalone ceramic when compared to autograft for posterolateral spinal fusion. These results suggest the need for larger trials with longer duration of follow-up.

Radiologic Assessment of Interbody Fusion: A Systematic Review on the Use, Reliability, and Accuracy of Current Fusion Criteria.

BACKGROUND: Lumbar interbody fusion (IF) is a common procedure to fuse the anterior spine. However, a lack of consensus on image-based fusion assessment limits the validity and comparison of IF studies. This systematic review aims to (1) report on IF assessment strategies and definitions and (2) summarize available literature on the diagnostic reliability and accuracy of these assessments. METHODS: Two searches were performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Search 1 identified studies on adult lumbar IF that provided a detailed description of image-based fusion assessment. Search 2 analyzed studies on the reliability of specific fusion criteria/classifications and the accuracy assessed with surgical exploration. RESULTS: A total of 442 studies were included for search 1 and 8 studies for search 2. Fusion assessment throughout the literature was highly variable. Eighteen definitions and more than 250 unique fusion assessment methods were identified. The criteria that showed most consistent use were continuity of bony bridging, radiolucency around the cage, and angular motion <5°. However, reliability and accuracy studies were scarce. CONCLUSION: This review highlights the challenges in reaching consensus on IF assessment. The variability in IF assessment is very high, which limits the translatability of studies. Accuracy studies are needed to guide innovations of assessment. Future IF assessment strategies should focus on the standardization of computed tomography-based continuity of bony bridging. Knowledge from preclinical and imaging studies can add valuable information to this ongoing discussion. LEVEL OF EVIDENCE: Diagnostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Comment on Burgos et al. Fusionless All-Pedicle Screws for Posterior Deformity Correction in AIS Immature Patients Permit the Restoration of Normal Vertebral Morphology and Removal of the Instrumentation Once Bone Maturity Is Reached. J. Clin. Med. 2023, 12, 2408.

With great interest, we read the recently published paper "Fusionless All-Pedicle Screws for Posterior Deformity Correction in AIS Immature Patients Permit the Restoration of Normal Vertebral Morphology and Removal of the Instrumentation Once Bone Maturity is Reached" by Burgos et al. [...].

The three-dimensional coupling mechanism in scoliosis and its consequences for correction.

INTRODUCTION: In idiopathic scoliosis, the anterior spinal column has rotated away from the midline and has become longer through unloading and expansion of the intervertebral discs. Theoretically, extension of the spine in the sagittal plane should provide room for this longer anterior spinal column, allowing it to swing back towards the midline in the coronal and axial plane, thus reducing both the Cobb angle and the apical vertebral rotation. METHODS: In this prospective experimental study, ten patients with primary thoracic adolescent idiopathic scoliosis (AIS) underwent MRI (BoneMRI and cVISTA sequences) in supine as well as in an extended position by placing a broad bolster, supporting both hemi-thoraces, under the scoliotic apex. Differences in T4-T12 kyphosis angle, coronal Cobb angle, vertebral rotation, as well as shape of the intervertebral disc and shape and position of the nucleus pulposus, were analysed and compared between the two positions. RESULTS: Extension reduced T4-T12 thoracic kyphosis by 10° (p < 0.001), the coronal Cobb angle decreased by 9° (p < 0.001) and vertebral rotation by 4° (p = 0.036). The coronal wedge shape of the disc significantly normalized and the wedged and lateralized nucleus pulposus partially reduced to a more symmetrical position. CONCLUSION: Simple extension of the scoliotic spine leads to a reduction of the deformity in the coronal and axial plane. The shape of the disc normalizes and the eccentric nucleus pulposus partially moves back to the midline.