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.

Study Overview

• Status: Completed
• Conditions: Sacral Fracture
• Intervention / Treatment: Procedure: spinopelvic fixation

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.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Slovakia
  • Banska Bystrica, Slovakia, 97517
    • F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients operated at our institution

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients operated with open spinopelvic fixation; patients with vertically unstable high-energy sacral fracture operated with traditionally open spinopelvic fixation	Procedure: spinopelvic fixation; open and minimally invasive spinopelvic fixation for unstable or dislocated high-energy sacral fractures
patients operated with minimally invasive 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	in perioperative period
length of the surgical procedure	length of the surgical procedure from the first incision to the suture of the wounds	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)	in perioperative period
pelvic ring symmetry	position of fracture fragments before and after surgery measured in three planes on CT scan	up to 1 year
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.	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.	1 year

Collaborators and Investigators

• Sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
• Investigators: Principal Investigator: Tomas Hrin, MD, F.D. Roosevelt Teaching Hospital with Policlinic

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 16, 2024
• Study Completion (Actual): December 18, 2024

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 12/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: plan to share all collected IPD
• IPD Sharing Time Frame: starting in January 2025
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No