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Single Trans-sacral Screw Versus Two Iliosacral Screws

A

Assiut University

Status

Unknown

Conditions

Pelvic Fracture

Treatments

Procedure: Fixation of unstable pelvic fractures

Study type

Observational

Funder types

Other

Identifiers

NCT03944174
Trans-sacral screw fixation

Details and patient eligibility

About

  1. To compare Single Trans-sacral screw fixation vs. two Ilio-Sacral screws fixation as regard time for starting weight bearing.
  2. To compare between functional outcome using the Majeed Pelvic Score.

Full description

Sacroiliac screws (SISs) have been used since Vidal et al introduced them in 1973. Since that, SIS fixation has become a common technology in fixing pelvic posterior ring injuries with important progress in the past 20 years. Currently, SIS fixation represents the only minimally invasive technique to stabilize the posterior pelvic ring. For that reason, it is steadily gaining popularity, becoming one of the most commonly used techniques. The sacrum, serving as the foundation of the spine, transmits the stress between spine and pelvis through sacroiliac joints. Thus, the goal of surgical fixation is the reconstruction of the spino-pelvic-junction to allow early weight-bearing and to facilitate nursing care, particularly for multiple injured patients.

As a result of the deforming forces acting perpendicular to the implant axis, routine ilio-sacral screws fixation may not provide adequate stabilization, especially in certain unstable injuries. Longer trans-sacral screws that traverse the entire upper sacrum and exit the contralateral iliac cortex may improve holding power and also stabilize concomitant contralateral posterior pelvic injuries. These trans-sacral screws are reliably safe to insert using routine intraoperative fluoroscopy, and they provide durable fixation.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Unstable pelvic fractures Tile type B & C.
  2. Sacral Fractures.
  3. Recent trauma: less than 1 week from date of trauma.
  4. Neurologically free.
  5. Injury Severity Score (ISS) < 18.

Exclusion criteria

  1. Spino-pelvic dissociation.
  2. Comminuted fractures
  3. Bilat. Sacral fractures.
  4. Sacral insufficiency.
  5. Patients with associated comorbidities "eg. uncontrolled diabetes mellitus , chronic renal failure, etc.".

Trial design

60 participants in 2 patient groups

Single Trans-sacral Screw
Treatment:
Procedure: Fixation of unstable pelvic fractures
Two Iliosacral Screws
Treatment:
Procedure: Fixation of unstable pelvic fractures

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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