Fixation of Unstable Sacral Fractures by Transpedicular System

Completed

• Conditions: Fixation; Unstable Sacral Fractures; Transpedicular Sacral Fixation

• Registration Number: NCT06888583
• Lead Sponsor: Tanta University

Brief Summary

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

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 Timeline

• Study Start: 2022-05-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-15
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional outcome	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).

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt