Clinical trial NCT06755580: Comparison of Minimally Invasive Versus Open Spinopelvic Fixation for Unstable Sacral Fractures
Official title: Comparison of Minimally Invasive Versus Open Spinopelvic Fixation for Unstable Sacral Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sacral Fracture
Lead sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 51
Sex: ALL
Minimum age (years): 16
Maximum age (years): 77
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients operated at our institution

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patient with high energy vertically unstable sacral fracture
* patients operated with open or minimally invasive spinopelvic fixation
* patients followed up for at least one year

Exclusion Criteria:

* patients with low-energy osteoporotic fractures of the sacrum
* patients with insufficiency fractures of the sacrum
* patients operated on using a method other than spinopelvic fixation
* patients who were not followed up for at least one year after surgery

Primary outcomes:
measure: pelvic ring symmetry
timeFrame: up to 1 year
measure: invasiveness of the surgical procedure
timeFrame: in perioperative period
measure: length of the surgical procedure
timeFrame: in perioperative period
measure: radiation exposure of the patient during surgical procedure
timeFrame: in perioperative period
measure: Functional outcome after surgery based on a standardized questionnaire according to the Majeed score
timeFrame: one year after surgery
measure: complications
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Banska Bystrica
country: Slovakia
facility: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Study officials:
affiliation: F.D. Roosevelt Teaching Hospital with Policlinic
name: Tomas Hrin, MD
role: PRINCIPAL_INVESTIGATOR
References: