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Summary: precise percutaneous pedicle screw (pps) placement is essential in preventing neurological complications and improving patient outcomes.In this retrospective study, patients were investigated who underwent posterior instrumentation with ppss in the thoracic to lumbar spine, utilizing an intraoperative ct navigation system, between (b)(6) 2019 and (b)(6) 2023.Study included 170 patients (151 undergoing llif procedures and 19 trauma patients), resulting in 836 pps placements.The overall pps deviation rate, assessed using the ravi scale, was 2.5%, with a notably higher incidence of deviations observed in the thoracic spine (7.4%) compared to the lumbar spine (1.9%).No statistically significant difference in screw deviation rates between upside and downside pps placements.This retrospective study sheds light on the challenges associated with achieving precise pps placement in the lateral decubitus position, with a significantly higher deviation rate observed in the thoracic spine compared to the lumbar spine.This study emphasizes the need for ongoing research to improve pps insertion techniques, leading to enhanced patient outcomes in spine surgery.This study aims to assess the accuracy of pps placement retrospectively, using intraoperative ct navigation in the lateral position, for thoracic to lumbar spine conditions.Reported events: 93 patients (55%) underwent surgery at a single level, while 77 patients (45%) underwent surgery at two or more levels.Pred-op diagnosis diagnosis for the patient were lcs + (lds), dls, fs, dish fx, thoracolumbar fx ,ldh, synovial cyst, spondylitis.The o-arm2 was used to capture 3d fluoroscopic images, which were transferred to the stealth station surgical navigation system for spinal navigation.Intraoperative ct navigation imaging was performed once for all cases.With the assistance of a computer-aided design derived from the navigation system, the pps was ready to be inserted.The first step involved making a skin incision guided by virtual lines from the computer-aided design model.After this, an appropriate pilot hole was created using the stealth-midas system, another tool by medtronic.This pilot hole served as a guide for the screw.Once the pilot hole is ready, the pps was inserted with the help of the powerase driver.The pps was inserted sequentially starting from near the reference frame.After the insertion of the pps, we confirmed its position solely using fluoroscopy.In our study, the recorded operation time spanned the entire operation, covering both the llif procedure and the pps placement.About 1¿2weeks after surgery, patients underwent a postoperative ct scan to assess pps placement accuracy.Pps positioning was evaluated using postoperative 3 mm slice ct scans and a specific scoring system.The best positioning options were the ia and the ib types.The iia or iib position must be evaluated for stabilitybut usually does not require a revision.In the iiia and iiib malpositions, depending on stability or possible neurological irritation, a screw revision must be considered.This classification system describes the screw placement in the pedicle with particular focus on medial, lateral deviation from the optimal position.In terms of perioperative complications, three patients had issues related to intraoperative ct navigation.One patient experienced a wound infection and two faced lower limb paralysis from pps placement.Two patients faced postoperative neurological deficit (pps-related) and one patient died perioperatively.This patient was a 77-year-old female with a history of interstitial pneumonia and rheumatoid arthritis, requiring steroid medication.She underwent an aortic dissection ascending replacement procedure.Following the surgery, she developed a pseudoaneurysm at the anastomosis site which was then corrected by cardiovascular surgery.The day after the surgery, she went into circulatory failure, necessitating a re-thoracotomy.The cause of bleeding remained unidentified until intercostal artery embolization was performed through interventional radiology to stop the hemorrhage.At that time, a ct scan revealed a dish fracture, leading to a posterior fusion procedure from t6 to t12.After various surgeries, she suffered from a massive retroperitoneal hemorrhage, disseminated intravascular coagulation, and multi-organ failure, leading to her unfortunate passing.Additionally, six patients required reoperation, which included cases involving re-decompression at the same level or pps replacement.Two patients with 2b inner position abnormalities (two screws) were identified in the thoracic spine, occurring at t7 and t12.In contrast, we observed two patients (three screws) in the lumbar spine, with one at l3 and two at l5.Furthermore, among patients with 3b inner position abnormalities, we found two patients (three screws) in the thoracic spine, one at t6 and two at t11.There were no deviations in the lumbar spine for the patients with 3b conclusion: the study highlighted the difficulties in achieving precise pps placement using lss, especially in the thoracic spine.The inaccuracy rate of 7.4% in the thoracic spine, compared to 1.9% in the lumbar spine, clearly indicates the need for improvement in this surgical approach for the thoracic spin.
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Akihiko hiyama, daisuke sakai, hiroyuki katoh, satoshi nomura and masahiko watanabe."assessing procedural accuracy in lateral spine surgery: a retrospective analysis of percutaneous pedicle screw placement with intraoperative ct navigation " journal of clinical m edicine.2023, 12,6914.Https://doi.Org/10.3390/jcm12216914 b3: date that the article was published for as the event dates were not provided in the published literature.D1: brand name is unknown.D4: product identifiers are unknown.D section 6a, 6b: implant, explant date unknown.G4: 510(k)# is unknown.H6: neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Digital sharing of the article would be in violation of copyright permission.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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