An observational study in Sacral Fracture, sponsored by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica. Completed at 1 site in Slovakia. Open to participants aged 16 Years to 77 Years. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica · Observational
The aim of this retrospective study is to evaluate patients with vertically unstable high-energy sacral fracture operated on at our institution with spinopelvic fixation, to compare the traditionally open method of fixation with the minimally invasive fixation. The aim of the research is to determine whether minimally invasive surgical techniques can achieve comparable fracture reduction and functional outcome as open surgical approaches. Another aim is to determine whether the minimally invasive surgical procedure leads to shorter patient hospitalization, lower perioperative blood loss, and lower postoperative complications.
This retrospective study included 51 patients with vertically unstable sacral fracture operated at our institution with open or minimally invasive spinopelvic fixation over a period of 11 years (2014-2024). The patients were divided into two groups. One group of patients underwent open spinopelvic fixation, the other group underwent minimally invasive spinopelvic fixation. Each patient underwent a CT scan before and after surgery. The degree of fracture dislocation and reduction was measured in three planes at each examination. The degree of reduction was divided into four groups according to residual dislocation. In the perioperative period, blood loss, the length of the surgical procedure from the first incision to the suture of the wounds, and radiation exposure were monitored. Intraoperative blood loss was calculated from the waste in the surgical suction system. Functional outcome was assessed one year after surgery. A standardized questionnaire according to the Majeed score was used to assess functional outcome.
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
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patients operated at our institution
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Exclusion Criteria:
patients with vertically unstable high-energy sacral fracture operated with traditionally open spinopelvic fixation
Procedure: spinopelvic fixation
patients with vertically unstable high-energy sacral fracture operated with minimally invasive spinopelvic fixation
Procedure: spinopelvic fixation
open and minimally invasive spinopelvic fixation for unstable or dislocated high-energy sacral fractures
pelvic ring symmetry
position of fracture fragments before and after surgery measured in three planes on CT scan
Time frame: up to 1 year
invasiveness of the surgical procedure
The invasiveness of the surgical procedure was measured based on perioperative blood loss. Perioperative blood loss was calculated from the waste in the surgical suction system (mililiters)
Time frame: in perioperative period
length of the surgical procedure
length of the surgical procedure from the first incision to the suture of the wounds
Time frame: in perioperative period
radiation exposure of the patient during surgical procedure
radiation exposure of a patient during a surgical procedure measured by the X-ray machine used during the operation (microgray/m2)
Time frame: in perioperative period
Functional outcome after surgery based on a standardized questionnaire according to the Majeed score
One year after surgery, patients fill out a standardized questionnaire according to the Majeed scoring system. Majeed score is a pelvic injury-specific functional assessment that comprises seven items, including pain, work, sitting, sexual intercourse, standing, unaided gait, and walking distance, with a total score range of 0 (worst outcome) to100 (best outcome), in order of decreasing disability.
Time frame: one year after surgery
complications
During the observation period, postoperative complications such as wound infection, loosening of osteosynthetic material, loss of reduction, nonunion, and newly developed neurological deficit will be recorded in patients.
Time frame: 1 year
Plan to share: Yes — plan to share all collected IPD
Supporting information: Study protocol, Clinical study report
Time frame: starting in January 2025
Access criteria: Data will be shared with medical journals for the purpose of publishing , with Slovak Medical University and with Slovak Medical Library for the purpose of clinical study report
No publications or documents are linked to this record.
Ran from Jan 2014 to primary completion in Dec 2024, 131 months.
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica