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Completed

NCT Number: NCT06888583

Fixation of Unstable Sacral Fractures by Transpedicular System

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transpedicular fixation

Procedure

Patients underwent transpedicular sacral fixation.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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