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"Distefano, Daniela"
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The 'armed concrete' approach: stent-screw-assisted internal fixation (SAIF) reconstructs and internally fixates the most severe osteoporotic vertebral fractures
2021
BackgroundThe treatment of severe osteoporotic vertebral compression fractures (VCFs) with middle-column (MC) involvement, high fragmentation, large cleft and/or pedicular fracture is challenging. Minimally invasive 'stent-screw-assisted internal fixation' (SAIF) can reduce the fracture, reconstruct the vertebral body (VB) and fix it to the posterior elements.ObjectiveTo assess feasibility, safety, technical and clinical outcome of the SAIF technique in patients with severe osteoporotic VCFs.Methods80 treated vertebrae were analyzed retrospectively. Severe VCFs were characterized by advanced collapse (Genant grade 3), a high degree of osseous fragmentation (McCormack grade 2 and 3), burst morphology with MC injury, pediculo-somatic junction fracture, and/or large osteonecrotic cleft. VB reconstruction was evaluated on postprocedure radiographs and CT scans by two independent raters. Clinical and radiological follow-ups were performed at 1 and 6 months.ResultsSAIF was performed at 28 thoracic and 52 lumbar levels in 73 patients. One transient neurological complication occurred. VB reconstruction was satisfactory in 98.8% of levels (inter-rater reliability 96%, κ=1). Follow-up at 1 month was available for 78/80 levels and at 6 months or later (range 6–24, mean 7.9 months) for 73/80 levels. Significant improvement in the Visual Analog Scale score was noted at 1 and 6 months after treatment (p<0.05). Patients reported global clinical benefit during follow-up (Patient’s Global Impression of Change Scale 5.6±0.9 at 1 month and 6.1±0.9 at 6 months). Fourteen new painful VCFs occurred at different levels in 11 patients during follow-up, treated with vertebral augmentation or SAIF. Target-level stability was maintained in all cases.ConclusionsSAIF is a minimally invasive, safe, and effective treatment for patients with severe osteoporotic VCFs with MC involvement.
Journal Article
Stent-screw-assisted internal fixation: the SAIF technique to augment severe osteoporotic and neoplastic vertebral body fractures
by
Distefano, Daniela
,
Isalberti, Maurizio
,
Hirsch, Joshua A
in
Back pain
,
Cancer therapies
,
Cement
2019
ObjectivesTo describe a new technique to obtain minimally invasive but efficient vertebral body (VB) reconstruction, augmentation, and stabilization in severe osteoporotic and neoplastic fractures, combining two pre-existing procedures. The implant of vertebral body stents (VBS) is followed by insertion of percutaneous, fenestrated, cement-augmented pedicular screws that act as anchors to the posterior elements for the cement/stent complex. The screws reduce the risk of stent mobilization in a non-intact VB cortical shell and bridge middle column and pedicular fractures. This procedure results in a 360° non-fusion form of vertebral internal fixation that may empower vertebral augmentation and potentially avoid corpectomy in challenging fractures.Procedure detailsThis report provides step-by-step procedural details, rationale, and proposed indications for this procedure. The procedure is entirely percutaneous under fluoroscopic guidance. Through transpedicular trocars the VBS are inserted, balloon-expanded and implanted in the VB. Over k-wire exchange the transpedicular screws are inserted inside the lumen of the stents and cement is injected through the screws to augment the stents and fuse the screws to the stents.ApplicationsThis technique may find appropriate applications for the most severe osteoporotic fractures with large clefts, high-degree fragmentation and collapse, middle column and pedicular involvement, and in extensive neoplastic lytic lesions.ConclusionsStent-Screw-Assisted Internal Fixation (SAIF) might represent a minimally invasive option to obtain VB reconstruction and restoration of axial load capability in severe osteoporotic and neoplastic fractures, potentially obviating the need for more invasive surgical interventions in situations that would pose significant challenges to standard vertebroplasty or balloon kyphoplasty.
Journal Article
Stent-Screw Assisted Internal Fixation of Osteoporotic Vertebrae: A Comparative Finite Element Analysis on SAIF Technique
by
Ferrari, Andrea
,
Villa, Tomaso
,
Bonaldi, Giuseppe
in
Balloon treatment
,
Bioengineering and Biotechnology
,
Biomechanics
2019
Vertebral compression fractures are one of the most relevant clinical consequences caused by osteoporosis: one of the most common treatment for such fractures is vertebral augmentation through minimally invasive approaches (vertebroplasty or balloon-kyphoplasty). Unfortunately, these techniques still present drawbacks, such as re-fractures of the treated vertebral body with subsidence of the non-augmented portions or re-fracture of the non-augmented middle column at the junction with the augmented anterior column. A novel minimally-invasive augmentation technique, called Stent-Screw Assisted Internal Fixation, has been recently proposed for the treatment of severe osteoporotic and neoplastic fractures: this technique uses two vertebral body stents and percutaneous cannulated and fenestrated pedicular screws, through which cement is injected inside the expanded stents to achieve optimal stents' and vertebral body's filling. The role of the pedicle screws is to anchor the stents-cement complex to the posterior column, acting as a bridge across the middle column and preserving its integrity from possible collapse. In order to evaluate the potential of the new technique in restoring the load bearing capacity of the anterior and middle spinal columns and in reducing bone strains, a Finite Element model of an osteoporotic lumbar spine has been developed. Both standard vertebroplasty and Stent-Screw Assisted Internal Fixation have been simulated: simulations have been run taking into account everyday activities (standing and flexion) and comparison between the two techniques, in terms of strain distribution on vertebral endplates and posterior and anterior wall, was performed. Results show that Stent-Screw Assisted Internal Fixation significantly decrease the strain distribution on the superior EP and the cortical wall compared to vertebroplasty, possibly reducing the re-fracture risk of the middle-column at the treated level.
Journal Article
Mechanical Cavity Creation with Curettage and Vacuum Suction (Q-VAC) in Lytic Vertebral Body Lesions with Posterior Wall Dehiscence and Epidural Mass before Cement Augmentation
2019
Background and Objectives: We describe a novel technique for percutaneous tumor debulking and cavity creation in patients with extensive lytic lesions of the vertebral body including posterior wall dehiscence prior to vertebral augmentation (VA) procedures. The mechanical cavity is created with a combination of curettage and vacuum suction (Q-VAC). Balloon kyphoplasty and vertebral body stenting are used to treat neoplastic vertebral lesions and might reduce the rate of cement leakage, especially in presence of posterior wall dehiscence. However, these techniques could theoretically lead to increased intravertebral pressure during balloon inflation with possible mobilization of soft tissue tumor through the posterior wall, aggravation of spinal stenosis, and resultant complications. Creation of a void or cavity prior to balloon expansion and/or cement injection would potentially reduce these risks. Materials and Methods: A curette is coaxially inserted in the vertebral body via transpedicular access trocars. The intravertebral neoplastic soft tissue is fragmented by multiple rotational and translational movements. Subsequently, vacuum aspiration is applied via one of two 10 G cannulas that had been introduced directly into the fragmented lesion, while saline is passively flushed via the contralateral cannula, with lavage of the fragmented solid and fluid-necrotic tumor parts. Results: We applied the Q-VAC technique to 35 cases of thoracic and lumbar extreme osteolysis with epidural mass before vertebral body stenting (VBS) cement augmentation. We observed extravertebral cement leakage on postoperative CT in 34% of cases, but with no clinical consequences. No patients experienced periprocedural respiratory problems or new or worsening neurological deficit. Conclusion: The Q-VAC technique, combining mechanical curettage and vacuum suction, is a safe, inexpensive, and reliable method for percutaneous intravertebral tumor debulking and cavitation prior to VA. We propose the Q-VAC technique for cases with extensive neoplastic osteolysis, especially if cortical boundaries of the posterior wall are dehiscent and an epidural soft tissue mass is present.
Journal Article
Precision Neuromodulation Treatment Reverses Motor and Cognitive Slowing After Stroke: Clinical and Neurophysiological Evidence
2026
Background/Objectives: Chronic psychomotor and cognitive slowing after stroke can persist despite standard rehabilitation, especially in young adults with subcortical injuries. Innovative, integrated interventions are crucial for patients who have reached a plateau in their rehabilitation. We present a case of a 41-year-old male with chronic psychomotor and cognitive slowing following a left lenticulostriate infarction (NIHSS score = 5 at onset), who had plateaued after conventional rehabilitation. Methods: Over 4 weeks the patient underwent 20 sessions of a multimodal approach including high-frequency repetitive transcranial magnetic resonance stimulation over the supplementary motor area and bilateral temporo-parietal junctions and simultaneous computerized cognitive training targeting attention and executive function. Both motor and cognitive assessments, along with quantitative EEG (qEEG) evaluations, were conducted before and after the treatment. Results: At the end of treatment, the patient showed significant clinical improvement: speed and coordination in upper extremities (Finger Tapping Test) increased by 66% (dominant hand) and 74% (non-dominant hand), while finger dexterity (Nine-Hole Peg Test) increased by 25% (dominant hand) and 19% (non-dominant hand). Cognitive scores improved in alertness (58%), visual exploration (25%), and flexibility (24%), while divided attention remained stable. qEEG investigation showed increases in alpha (79%), gamma (33%), and beta (10%) power, with topographic shifts in the stimulated regions. Conclusions: These findings highlight the feasibility of combining targeted rTMS and cognitive training to enhance neuroplasticity in the chronic phase of stroke. Clinical recovery was accompanied by normalized cortical rhythms, suggesting qEEG biomarkers may be useful for tracking treatment response. Multimodal precision neurorehabilitation may offer a path forward for patients with persistent cognitive–motor deficits post-stroke.
Journal Article
Percutaneous thoraco-lumbar-sacral pedicle screw placement accuracy results from a multi-center, prospective clinical study using a skin marker-based optical navigation system
2022
Study designProspective multi-center study.ObjectiveThe study aimed to evaluate the accuracy of pedicle screw placement using a skin marker-based optical surgical navigation system for minimal invasive thoraco-lumbar-sacral pedicle screw placement.MethodsThe study was performed in a hybrid Operating Room with a video camera-based navigation system integrated in the imaging hardware. The patient was tracked with non-invasive skin markers while the instrument tracking was via an on-shaft optical marker pattern. The screw placement accuracy assessment was performed by three independent reviewers, using the Gertzbein grading. The screw placement time as well as the staff and patient radiation doses was also measured.ResultsIn total, 211 screws in 39 patients were analyzed for screw placement accuracy. Of these 32.7% were in the thoracic region, 59.7% were in the lumbar region, and 7.6% were in the sacral region. An overall accuracy of 98.1% was achieved. No screws were deemed severely misplaced (Gertzbein grading 3). The average time for screw placement was 6 min and 25 secs (± 3 min 33 secs). The average operator radiation dose per subject was 40.3 µSv. The mean patient effective dose (ED) was 11.94 mSv.ConclusionSkin marker-based ON can be used to achieve very accurate thoracolumbarsacral pedicle screw placements.
Journal Article
Imaging of spinal cord compression
2014
A wide spectrum of conditions may compress the spinal cord: degenerative disease, disc herniation and neoplasms are the most common causes; other conditions include trauma, epidural abscess and hematoma. The role of imaging is to establish a radiological diagnosis, to distinguish intrinsic spinal cord disease from extrinsic compression, to define mechanical spine stability and to evaluate the integrity of neural tissue. Clinical presentation, variable in severity and patterns of progression, influences the imaging approach. Imaging is required to assess osseous structures and soft tissues. The need to image 'across anatomical compartments' usually requires more than one imaging technique. Multidetector CT is the first-line imaging modality in acute spine trauma. MRI is the best imaging modality to assess soft tissues, image the extradural, intradural and spinal cord compartments. MRI needs to be implemented with fat-suppression techniques applied to T
- and contrast-enhanced T
-weighted sequences. MRI helps predict neurological recovery, providing macroscopic information including both reversible and irreversible histologic changes. Diffusion tensor imaging enables depiction of microstructural changes in the compressed spinal cord, which could further predict tissue viability, and functional prognosis. The role of CT myelography is reserved to selected cases, when MRI is not feasible or results are unclear but, intrathecal injection of contrast from below and above the compression level might be necessary to overcome the diagnostic limitations imposed by a myelographic block. This article summarizes the capabilities and limits of different imaging modalities in the spinal cord compression scenario, suggesting technical imaging protocols and diagnostic pathways, and discusses imaging aspects of various causes of spinal cord compression, following an organization based on their anatomical compartment of origin: osseous, epidural or intradural.
Journal Article
Vertebral body stent augmentation to reconstruct the anterior column in neoplastic extreme osteolysis
2019
BackgroundExtensive lytic lesions of the vertebral body (VB) increase risk of fracture and instability and require stabilization of the anterior column. Vertebral augmentation is an accepted treatment option, but when osteolysis has extensively destroyed the VB cortical boundaries (a condition herein defined as ‘extreme osteolysis’), the risk of cement leakage and/or insufficient filling is high. Vertebral body stents (VBSs) might allow partial restoration of VB height, cement containment, and reinforcement, but their use in extreme osteolysis has not been investigated.ObjectiveTo assess retrospectively the feasibility and safety of VBS augmentation in patients with ‘extreme osteolysis’ of the VB.MethodsWe retrospectively analyzed 41 treated vertebrae (from T1 to L5). VB reconstruction was assessed on postprocedure CT images and rated on a qualitative 4-point scale (poor-fair-good-excellent). Clinical and radiological follow-up was performed at 1 month and thereafter at intervals in accordance with oncological protocols.ResultsVBS augmentation was performed at 12 lumbar and 29 thoracic levels, with bilateral VBS in 23/41. VB reconstruction was judged satisfactory (good or excellent) in 37/41 (90%) of levels. Bilateral VBS received higher scores than unilateral (p=0.057, Pearson’s X2). We observed no periprocedural complications. Cement leaks (epidural or foraminal) occurred at 5/41 levels (12.2%) without clinical consequences. Follow-up data were available for 27/29 patients, extending beyond 6 months for 20 patients (7–28 months, mean 15.3 months). VBS implant stability was observed in 40/41 cases (97.5%).ConclusionsOur results support the use of VBS as a minimally invasive, safe and effective option for reconstructing the anterior column in prominent VB osteolysis.
Journal Article
Sleep-Related Breathing Disorders in Multiple Sclerosis: Prevalence, Features and Associated Factors
by
Haba-Rubio, José
,
Fanfulla, Francesco
,
Distefano, Daniela
in
Comparative analysis
,
Fatigue
,
Medical research
2022
Multiple sclerosis (MS) represents a risk factor for sleep disorders, but there are conflicting results about the prevalence and severity of sleep-related breathing disorders (SRBD) in MS. Most available data come from self-administered questionnaires.
To conduct a polysomnographic study in MS focused on SRBD, compared to a group of healthy controls (HC), also considering the neuroimaging findings. To evaluate the impact of SRBD on vigilance, fatigue and depression in MS.
In this cross-sectional, observational, instrumental study, 67 MS patients (men/women: 20/47; mean age: 50.6±8.2 years) underwent PSG and maintenance of wakefulness test. Findings were compared to 67 age-, sex-, BMI-matched HC, by using parametric (Student's
-test) and nonparametric statistics (chi-squared test). A subgroup analysis was then performed, evaluating the influence of brainstem (mesencephalic, pontine and medullary) lesions at neuroimaging on instrumental and clinical data: MS patients with at least one brainstem lesion vs MS patients without vs HC.
The frequency of SRBD was comparable in MS patients and HC. No MS patient had a central apnea index ≥2/h. The respiratory disturbance index (RDI) did not correlate to clinical parameters such as fatigue and depression. Patients with MS were drowsier than HC (47% vs 26%, p = 0.019) and showed a worse sleep pattern, in terms of duration, efficiency and architecture.
Our study does not provide evidence of an association between MS-specific symptoms such as fatigue, sleepiness, depression and central or obstructive apneas, even in the presence of brainstem lesions.
Journal Article