Pedicle screw placement accuracy in robot-assisted versus image-guided freehand surgery of thoraco-lumbar spine (ROBARTHRODESE): study protocol for a single-centre randomized controlled trial.

BACKGROUND: Robotic spinal surgery may result in better pedicle screw placement accuracy, and reduction in radiation exposure and length of stay, compared to freehand surgery. The purpose of this randomized controlled trial (RCT) is to compare screw placement accuracy of robot-assisted surgery with integrated 3D computer-assisted navigation versus freehand surgery with 2D fluoroscopy for arthrodesis of the thoraco-lumbar spine. METHODS: This is a single-centre evaluator-blinded RCT with a 1:1 allocation ratio. Participants (n = 300) will be randomized into two groups, robot-assisted (Mazor X Stealth Edition) versus freehand, after stratification based on the planned number of pedicle screws needed for surgery. The primary outcome is the proportion of pedicle screws placed with grade A accuracy (Gertzbein-Robbins classification) on postoperative computed tomography images. The secondary outcomes are intervention time, operation room occupancy time, length of stay, estimated blood loss, surgeon's radiation exposure, screw fracture/loosening, superior-level facet joint violation, complication rate, reoperation rate on the same level or one level above, functional and clinical outcomes (Oswestry Disability Index, pain, Hospital Anxiety and Depression Scale, sensory and motor status) and cost-utility analysis. DISCUSSION: This RCT will provide insight into whether robot-assisted surgery with the newest generation spinal robot yields better pedicle screw placement accuracy than freehand surgery. Potential benefits of robot-assisted surgery include lower complication and revision rates, shorter length of stay, lower radiation exposure and reduction of economic cost of the overall care. TRIAL REGISTRATION: ClinicalTrials.gov NCT05553028. Registered on September 23, 2022.

Management of Fournier's gangrene during the Covid-19 pandemic era: make a virtue out of necessity.

BACKGROUND: Fournier's gangrene (FG) is a necrotizing fasciitis caused by aerobic and anaerobic bacterial infection that involves genitalia and perineum. Males, in their 60 s, are more affected with 1.6 new cases/100.000/year. Main risk factors are diabetes, malignancy, inflammatory bowel disease. FG is a potentially lethal disease with a rapid and progressive involvement of subcutaneous and fascial plane. A multimodal approach with surgical debridement, antibiotic therapy, intensive support care, and hyperbaric oxygen therapy (HBOT) is often needed. We present the inpatient management of an FG case during the Covid-19 pandemic period. A narrative review of the Literature searching "Fournier's gangrene", "necrotizing fasciitis" on PubMed and Scopus was performed. CASE PRESENTATION: A 60 years old man affected by diabetes mellitus, with ileostomy after colectomy for ulcerative colitis, was admitted to our Emergency Department with fever and acute pain, edema, dyschromia of right hemiscrotum, penis, and perineal region. Computed tomography revealed air-gas content and fluid-edematous thickening of these regions. Fournier's Gangrene Severity Index was 9. A prompt broad-spectrum antibiotic therapy with Piperacillin/Tazobactam, Imipenem and Daptomycin, surgical debridement of genitalia and perineal region with vital tissue exposure, were performed. Bedside daily surgical wound medications with fibrine debridement, normal saline and povidone-iodine solutions irrigation, iodoform and fatty gauze application, were performed until discharge on the 40th postoperative day. Every 3 days office-based medication with silver dressing, after normal saline and povidone-iodine irrigation and fibrinous tissue debridement, was performed until complete re-epithelialization of the scrotum on the 60th postoperative day. CONCLUSIONS: FG is burdened by a high mortality rate, up to 30%. In the literature, HBOT could improve wound restoration and disease-specific survival. Unfortunately, in our center, we do not have HBOT. Moreover, one of the pandemic period problems was the patient's displacement and outpatient hospital management. For all these reasons we decided for a conservative inpatient management. Daily cleaning of the surgical wound allowed to obtain its complete restoration avoiding surgical graft and hyperbaric oxygen chamber therapy, without foregoing optimal outcomes.

RéSUMé: CONTEXTE: La gangrène de Fournier (GF) est une fasciite nécrosante causée par une infection bactérienne aérobie et anaérobie qui implique les organes génitaux et le périnée. Les hommes, dans la soixantaine, sont plus touchés avec 1,6 nouveau cas/100 000/an. Les principaux facteurs de risque sont le diabète, les tumeurs malignes, et les maladies inflammatoires de l'intestin. La GF est une maladie potentiellement mortelle avec une atteinte rapide et progressive du plan sous-cutané et fascial. Une approche multimodale, avec débridement chirurgical, antibiothérapie, soins de soutien intensif et oxygénothérapie hyperbare (OHB), est souvent nécessaire. Nous présentons la prise en charge en milieu hospitalier d'un cas de GF pendant la période de pandémie de Covid-19. Une revue narrative de la littérature, recherchant «gangrène de Fournier¼, «fasciite nécrosante¼ sur PubMed et Scopus, a été réalisée. CAS CLINQUE: Un homme de 60 ans, atteint d'un diabète sucré et porteur d'une iléostomie après colectomie pour colite ulcéreuse, a été admis dans notre service d'urgences, avec fièvre et des douleurs aiguës, œdème et dyschromie de l'hémiscrotum droit, du pénis et de la région périnéale. La tomodensitométrie a révélé une teneur en air-gaz et un épaississement fluide-œdémateux de ces régions. L'indice de gravité de la gangrène de Fournier était de 9. Une antibiothérapie rapide à large spectre avec Pipéracilline/tazobactam, imipénème et daptomycine, et un débridement chirurgical des organes génitaux et de la région périnéale avec exposition des tissus vitaux, ont été effectués. Ont été réalisés au chevet du patient, un traitement quotidien des plaies chirurgicales, avec débridement de la fibrine, irrigation par solution saline normale et solution de povidone-iode, et application de gaze iodoforme et grasse, jusqu'à la décharge au 40èmejour postopératoire. Tous les 3 jours, un traitement à base de médicaments d'officine avec pansement à l'argent a été réalisé après irrigation par solution saline normale et solution de povidone-iode, et débridement de la fibrine des tissus, jusqu'à la ré-épithélialisation complète du scrotum au 60ème jour postopératoire. CONCLUSIONS: La GF est grevée d'un taux de mortalité élevé, jusqu'à 30%. Dans la littérature, l'OHB pourrait améliorer la restauration des plaies et la survie spécifique de la maladie. Malheureusement, dans notre centre, nous n'avons pas d'OHB. En outre, l'un des problèmes de la période pandémique était le déplacement du patient et la prise en charge ambulatoire des hôpitaux. Pour toutes ces raisons, nous avons opté pour une prise en charge conservatrice en milieu hospitalier. Le nettoyage quotidien de la plaie chirurgicale a permis d'obtenir sa restauration complète en évitant la greffe chirurgicale et la thérapie en chambre à oxygène hyperbare, sans renoncer à des résultats optimaux. MOTS-CLéS: Gangrène de Fournier, fasciite nécrosante, urgence urologique, débridement chirurgical.

Clinical evaluation of a lumbar interspinous dynamic stabilization device (the Wallis system) with a 13-year mean follow-up.

The authors determined current health status of patients who had been included in a long-term survivorship analysis of a lumbar dynamic stabilizer. Among 133 living patients, 107 (average age at surgery, 44.2 +/- 9.9 years) completed health questionnaires. All patients had initially been scheduled for decompression and fusion for canal stenosis, herniated disc, or both. In 20 patients, the implant was removed, and fusion was performed. The other 87 still had the dynamic stabilizer. Satisfaction, Oswestry disability index, visual analog scales for back and leg pain, short-form (SF-36) quality-of-life physical composite score, physical function, and social function were significantly better (p < or = 0.05) in the patients who still had the dynamic stabilization device. SF-36 scores of the fused subgroup were no worse than those reported elsewhere in patients who had primary pedicle-screw enhanced lumbar fusion. This anatomy-sparing device provided a good 13-year clinical outcome and obviated arthrodesis in 80% of patients.

Long-term actuarial survivorship analysis of an interspinous stabilization system.

In 1986, an interspinous dynamic stabilization system (the prototype of the current Wallis implant) was designed to stiffen unstable operated degenerate lumbar segments with a hard interspinous blocker to limit extension and a tension band around the spinous processes to secure the implant and limit flexion. Restoring physiological mechanical conditions to the treated level(s) while preserving some intervertebral mobility was intended to treat low-back pain related to degenerative instability without increasing stress forces in the adjacent segments. The procedure was easily reversible. If low back pain persisted or recurred, the device was removed and stability was achieved using fusion. The intermediate-term results were promising, but the long-term safety and efficacy of this dynamic interspinous stabilization device has not been previously documented. We retrospectively reviewed the hospital files of all the patients (n = 241) who had this dynamic stabilization system implanted between 1987 and 1995, contacting as many as possible to determine the actuarial survivorship of the system. In this manner, 142 of the 241 patients (58.9%) were contacted by telephone. The endpoints used for the survivorship analysis were 'any subsequent lumbar operation' and 'implant removal'. At 14 years follow-up, values of actuarial survivorship with 95% confidence interval were 75.9 +/- 8.3 and 81.3 +/- 6.8% for the endpoints 'any subsequent lumbar operation' and 'implant removal', respectively. There was no difference in survivorship of multiple-level implants with respect to single-level devices. Although the conclusions of the present study must be tempered by the 41% attrition rate, these findings support the long-term safety of this system, and possibly long-term protective action against adjacent-level degeneration by motion preservation. Outcomes at least equivalent to those of fusion were observed without the primary drawbacks of fusion.

Analysis of hard thoracic herniated discs: review of 18 cases operated by thoracoscopy.

The authors retrospectively reviewed a series of 18 hard thoracic herniated discs (HTHD) operated by thoracoscopy. Isolated cases of HTHD have been reported in the literature, but no series describing these lesions has been published. Seventy-two percent of the herniated discs were situated between T8 and T12. Fifty-six percent of the patients had radiographic sequelae of Scheuermann's disease. Postoperatively, 83% had neurological improvement. In seven cases (39%), a plane separating the herniated disc and the dura mater was found surgically. In 11 patients, no separating plane was found during surgery. The lesion was intradural in three patients (17%) and adherent to the dura mater in eight (44%). Among these 11 patients, surgery was complicated by a dural tear in the first seven that led to a high risk of cerebrospinal fluid fistula: four of these seven patients had required surgical revision. In the last four, the zone of adhesion of the HTHD to the dura mater was preserved, successfully preventing dural tear.