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

NCT ID: NCT06755580

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2024-12-18

Brief Summary

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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

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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.

Conditions

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Sacral Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients operated with open spinopelvic fixation

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

spinopelvic fixation

Intervention Type PROCEDURE

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

spinopelvic fixation

Intervention Type PROCEDURE

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

Interventions

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spinopelvic fixation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

OTHER

Sponsor Role lead

Responsible Party

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Hrin Tomas, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomas Hrin, MD

Role: PRINCIPAL_INVESTIGATOR

F.D. Roosevelt Teaching Hospital with Policlinic

Locations

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F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Banská Bystrica, , Slovakia

Site Status

Countries

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Slovakia

Other Identifiers

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12/2024

Identifier Type: -

Identifier Source: org_study_id

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