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NCT Number: NCT06755580

Comparison of Minimally Invasive Versus Open Spinopelvic Fixation for Unstable Sacral Fractures

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.

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Key information

Conditions

Sacral Fracture

Age range

16 year–77 year

Sex eligibility

All sexes

Study type

Observational

Primary location

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Banská Bystrica, 97517, Slovakia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

spinopelvic fixation

Procedure

open and minimally invasive spinopelvic fixation for unstable or dislocated high-energy sacral fractures

Primary outcomes

  1. pelvic ring symmetry

    Time frame: up to 1 year

    position of fracture fragments before and after surgery measured in three planes on CT scan

  2. invasiveness of the surgical procedure

    Time frame: in perioperative period

    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)

  3. length of the surgical procedure

    Time frame: in perioperative period

    length of the surgical procedure from the first incision to the suture of the wounds

  4. radiation exposure of the patient during surgical procedure

    Time frame: in perioperative period

    radiation exposure of a patient during a surgical procedure measured by the X-ray machine used during the operation (microgray/m2)

  5. Functional outcome after surgery based on a standardized questionnaire according to the Majeed score

    Time frame: one year after surgery

    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.

  6. complications

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Other

Registry information

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Jan 1, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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