Fixation of Unstable Sacral Fractures by Transpedicular System

March 20, 2025 updated by: Mohamed Elsayed Elmoghany, Tanta University
This research aimed to assess the role of the transpedicular Fixation system in the management of unstable sacral fractures in adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pelvic ring disruptions are high-energy injuries with a significant impact on quality of life and higher levels of mortality. Unstable sacral fracture is an unusual injury, and even though many studies implicate the surgical intervention as the treatment of choice, the purposes of surgery on sacral fractures include pelvic ring reconstruction, lumbopelvic stability restoration, fracture healing, early mobilization, fracture displacement prevention and improving the neurological deficiency. More and more surgeons are advocating for surgical management in the treatment of sacral fractures, and open reduction internal fixation (ORIF) has demonstrated marked benefits over conservative treatment.

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This prospective case series study was conducted on 21 patients with unstable sacral fractures at Tanta and Assiut University Hospitals from May 2022 to August 2024.

Description

Inclusion Criteria:

  • Adult patients over 18 years old age.
  • Both sexes.
  • Unstable AO sacral fracture type B and type C.
  • Patient fit for surgery and hemodynamic stable patient.
  • Closed fracture.

Exclusion Criteria:

  • AO sacral fracture type A.
  • Bedridden before the trauma.
  • Patient unfit for surgery.
  • Open sacral fractures.
  • Sacral fractures with massive morel-lavallee lesions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transpedicular fixation group
Patients underwent transpedicular sacral fixation.
Procedure: Transpedicular fixation
Patients underwent transpedicular sacral fixation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome
Time Frame: 1 year postoperatively
Function results were assessed in terms of pain, standing and sitting, sexual function, and the need of assistance when walking, walking distance, and gait according to scoring system proposed by Majeed score. Five factors were assessed and scored: pain (30 points), standing (36 points), sitting (10 points), sexual intercourse (4 points) and work performance (20 points). The total score then gave a clinical grade as excellent (>85 points), good (70-84 points), fair (55-69 points) or poor (<55 points).
1 year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

March 15, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35358/3/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fixation

Clinical Trials on Transpedicular fixation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe