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The goal of this clinical trial is to learn about the surgical techniques of percutaneous sacroiliac screw fixation both the two-view fluoroscopic technique (sacral inlet and outlet views) and the standard three-view fluoroscopic technique (lateral, sacral inlet, and sacral outlet views).
The main questions it aims to answer is:
• Is there any difference of the operative time, intraoperative radiation exposure time, screw malposition rate, and postoperative neurological complication rate for percutaneous pelvic screw fixation between two techniques?
Researchers will compare two surgical techniques of percutaneous sacroiliac screw fixation in high energy posterior pelvic ring injured patients.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous SI screw insertion using two fluoroscopic views | Active Comparator | Patients with posterior pelvic ring or sacral injuries resulting from high-energy trauma who required the sacroiliac screw fixation. Surgeon will insert the SI screw percutaneously using sacral inlet and sacral outlet fluoroscopic views |
|
| Percutaneous SI screw insertion using three fluoroscopic views | Active Comparator | Patients with posterior pelvic ring or sacral injuries resulting from high-energy trauma who required the sacroiliac screw fixation. Surgeon will insert the SI screw percutaneously using lateral, sacral inlet and sacral outlet fluoroscopic views |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous sacroiliac screw fixation using two or three fluoroscopic views | Procedure | Surgeon will insert the SI screw percutaneously using sacral inlet, sacral outlet fluoroscopic views with or without lateral sacral view |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Operative time in minutes that takes for insertion of guide pin of cannulated SI screw; From the time of skin incision to the final acceptable positioning of the guide pin (prior to screw insertion) | perioperative record |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Exposure Time | Cumulative fluoroscopy time in seconds; From the first fluoroscopic image to the final image confirming guide pin placement | Perioperative record |
| Neurological complications by physical examinations and symptoms |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Panachol Leangtanom | Chonburi hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonburi Hospital, 69 Moo 2 Sukhumvit Road | Chon Buri | Changwat Chon Buri | 20000 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36458444 | Background | Pei X, Zhou W, Wang GD, Cai XH, Zheng YF, Liu XM. Comparison of Three-Dimensional Navigation-Guided Percutaneous Iliosacral Screw and Minimally Invasive Percutaneous Plate for the Treatment of Zone II Unstable Sacral Fractures. Orthop Surg. 2023 Feb;15(2):471-479. doi: 10.1111/os.13561. Epub 2022 Dec 2. | |
| 26260867 | Background |
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Paticipants will undergo the operation with only one technique (either two-view fluoroscopy or three-view fluoroscopy)
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Neurological examinations will be assessed and recorded by an independent orthopedic resident blinded to the allocation. The evaluations include radiation pain by visual analog score, L5 and S1 motor power by physical examination motor grading scale, L5 and S1 sensation deficit (yes or no), perianal sensation deficit (yes or no), bowel bladder symptoms (yes or no), sphincter tone deficit (yes or no)
| Immediate postoperative to two months after operation |
| Screw malposition | Screw malpositions of S1 screw (yes or no) include cortical breakage (sacral ala, endplate, anterior cortex, ilium), foraminal penetration and canal penetration | Two months after operation, Postoperative CT scan will be evaluated for screw position. |
| Pishnamaz M, Dienstknecht T, Hoppe B, Garving C, Lange H, Hildebrand F, Kobbe P, Pape HC. Assessment of pelvic injuries treated with ilio-sacral screws: injury severity and accuracy of screw positioning. Int Orthop. 2016 Jul;40(7):1495-501. doi: 10.1007/s00264-015-2933-1. Epub 2015 Aug 11. |
| 30030551 | Background | Berger-Groch J, Lueers M, Rueger JM, Lehmann W, Thiesen D, Kolb JP, Hartel MJ, Grossterlinden LG. Accuracy of navigated and conventional iliosacral screw placement in B- and C-type pelvic ring fractures. Eur J Trauma Emerg Surg. 2020 Feb;46(1):107-113. doi: 10.1007/s00068-018-0990-z. Epub 2018 Jul 20. |
| 36324935 | Background | Zarei M, Moosavi M, Saghebdoust S, Shafizadeh M, Rostami M. Percutaneous iliosacral screw insertion with only outlet and inlet fluoroscopic view for unstable pelvic ring injuries: Clinical and radiological outcomes. Surg Neurol Int. 2022 Sep 30;13:455. doi: 10.25259/SNI_616_2022. eCollection 2022. |
| 36561220 | Background | Qoreishy M, Movahedinia M, Maleki A, Kazemi S. Safe Corridor for Sacroiliac Screw Insertion Can Be Found Quickly Without the Use of the Lateral Sacral View. Arch Bone Jt Surg. 2022 Nov;10(11):959-963. doi: 10.22038/ABJS.2022.60025.2956. |
| 39211565 | Background | Dehkhoda F, Manafi Rasi A, Zandi R, Abedi M, Ebadi SS. Percutaneous Sacroiliac Screw Fixation: A Modified Screw Insertion Method Using Just 2 Fluoroscopy Views. Arch Bone Jt Surg. 2024;12(8):574-579. doi: 10.22038/ABJS.2024.77855.3589. |
| 23748798 | Background | Zwingmann J, Hauschild O, Bode G, Sudkamp NP, Schmal H. Malposition and revision rates of different imaging modalities for percutaneous iliosacral screw fixation following pelvic fractures: a systematic review and meta-analysis. Arch Orthop Trauma Surg. 2013 Sep;133(9):1257-65. doi: 10.1007/s00402-013-1788-4. Epub 2013 Jun 8. |
| 11937873 | Background | Hinsche AF, Giannoudis PV, Smith RM. Fluoroscopy-based multiplanar image guidance for insertion of sacroiliac screws. Clin Orthop Relat Res. 2002 Feb;(395):135-44. doi: 10.1097/00003086-200202000-00014. |
| 12131388 | Background | van den Bosch EW, van Zwienen CM, van Vugt AB. Fluoroscopic positioning of sacroiliac screws in 88 patients. J Trauma. 2002 Jul;53(1):44-8. doi: 10.1097/00005373-200207000-00009. |
| 2706863 | Background | Matta JM, Saucedo T. Internal fixation of pelvic ring fractures. Clin Orthop Relat Res. 1989 May;(242):83-97. |
| 32723529 | Background | Florio M, Capasso L, Olivi A, Vitiello C, Leone A, Liuzza F. 3D - Navigated percutaneous screw fixation of pelvic ring injuries - a pilot study. Injury. 2020 Aug;51 Suppl 3:S28-S33. doi: 10.1016/j.injury.2020.07.025. Epub 2020 Jul 10. |
| 35705948 | Background | Kim CH, Kim JJ, Kim JW. Percutaneous posterior transiliac plate versus iliosacral screw fixation for posterior fixation of Tile C-type pelvic fractures: a retrospective comparative study. BMC Musculoskelet Disord. 2022 Jun 16;23(1):581. doi: 10.1186/s12891-022-05536-x. |
| 25031382 | Background | Kaiser SP, Gardner MJ, Liu J, Routt ML Jr, Morshed S. Anatomic Determinants of Sacral Dysmorphism and Implications for Safe Iliosacral Screw Placement. J Bone Joint Surg Am. 2014 Jul 16;96(14):e120. doi: 10.2106/JBJS.M.00895. |
| 23114418 | Background | Tabaie SA, Bledsoe JG, Moed BR. Biomechanical comparison of standard iliosacral screw fixation to transsacral locked screw fixation in a type C zone II pelvic fracture model. J Orthop Trauma. 2013 Sep;27(9):521-6. doi: 10.1097/BOT.0b013e3182781102. |
| 35077898 | Background | Liu F, Yu J, Yang H, Cai L, Chen L, Lei Q, Lei P. Iliosacral screw fixation of pelvic ring disruption with tridimensional patient-specific template guidance. Orthop Traumatol Surg Res. 2022 Apr;108(2):103210. doi: 10.1016/j.otsr.2022.103210. Epub 2022 Jan 22. |