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

NCT06755580 | Completed

• 1 other identifier: 12/2024
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacral Fracture

Outcome Measures

Primary Outcomes (6)

• pelvic ring symmetry

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

  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)

  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

• 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

Study Arms (2)

patients operated with open spinopelvic fixation

patients with vertically unstable high-energy sacral fracture operated with traditionally open spinopelvic fixation

Procedure: spinopelvic fixation

patients operated with minimally invasive spinopelvic fixation.

patients with vertically unstable high-energy sacral fracture operated with minimally invasive spinopelvic fixation

Procedure: spinopelvic fixation

Interventions

spinopelvic fixation PROCEDURE

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

patients operated with minimally invasive spinopelvic fixation.; patients operated with open spinopelvic fixation

Eligibility Criteria

• Age: 16 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients operated at our institution

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica: lead

Study Sites (1)

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Banská Bystrica, 97517, Slovakia

Location

Study Officials

• Tomas Hrin, MD

  F.D. Roosevelt Teaching Hospital with Policlinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 1, 2025
• Study Start: January 1, 2014
• Primary Completion: December 16, 2024
• Study Completion: December 18, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• 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

Locations

SL (1)