Fixation of Unstable Sacral Fractures by Transpedicular System

NCT06888583 | Completed

• 1 other identifier: 35358/3/22
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This research aimed to assess the role of the transpedicular Fixation system in the management of unstable sacral fractures in adults.

Conditions

Fixation; Unstable Sacral Fractures; Transpedicular Sacral Fixation

Outcome Measures

Primary Outcomes (1)

• Functional outcome

  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

Study Arms (1)

Transpedicular fixation group

Patients underwent transpedicular sacral fixation.

Procedure: Transpedicular fixation

Interventions

Transpedicular fixation PROCEDURE

Patients underwent transpedicular sacral fixation.

Transpedicular fixation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (1)

• Elmoghany ME, Gharbo NO, Ayoub MA, Farouk OA, Mashal HEY. Fixation of unstable sacral fractures by transpedicular system: a prospective study. Int Orthop. 2025 Nov 14. doi: 10.1007/s00264-025-06673-3. Online ahead of print.

  PMID: 41233652 DERIVED

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Orthopaedic surgery, Faculty of Medicine, Tanta University, Tanta, Egypt

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 21, 2025
• Study Start: May 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)