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Status unknownNCT03944174Updated May 10, 2019

Single Trans-sacral Screw Versus Two Iliosacral Screws

An observational study in Pelvic Fracture, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-05-10.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 60 Years
Sex
All
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Study summary

  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.
Read the detailed 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.

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Conditions studied

  • Pelvic Fracture

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03

In context

Hip Fractures

822 studies on the registry are indexed under Hip Fractures; 159 are open to participants now.

This study's planned enrollment of 60 is below the median of 140 across 268 observational studies indexed under Hip Fractures.

Browse Hip Fractures studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Any patient between 18 and 60 years old with unstable pelvic fracture admitted to the trauma unit of Assiut University Hospital

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

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.".
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Single Trans-sacral Screw

    Procedure: Fixation of unstable pelvic fractures

  • Two Iliosacral Screws

    Procedure: Fixation of unstable pelvic fractures

Interventions

  • ProcedureFixation of unstable pelvic fractures

    Percutaneous fixation of both iliac bones through the sacrum using one screw

06

What researchers measure

Primary outcomes

  1. Early painless weight bearing as tolerated measured by Visual Analogue Scale of Pain (VAS).

    Assessment the ability of the patient to start weight bearing without pain as soon as possible by the Visual Analogue Scale of Pain (VAS). It is a continuous scale comprised of a horizontal or vertical line, numbered from 0 to 10 and anchored by 2 verbal descriptors "no pain and worst imaginable pain" one for each symptom extreme from which the patient shall select the degree of pain varying from no pain to worst imaginable pain.

    Time frame: 2 weeks

  2. To measure the functional outcome using Majeed Pelvic Score system

    To assess the effect of the procedure on the daily activities of the patient after pelvic fractures. A system for assessment of function after major pelvic injuries is proposed. This numerical system developed from a five-year prospective study of 60 patients. Five factors were assessed and scored: pain, standing, sitting, sexual intercourse and work performance. The total score then gave a clinical grade as excellent, good, fair or poor. The scoring system allows comparison between early and late results and also between various methods of treatment.

    Time frame: 6 weeks and 6 months

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Study locations

No study locations are listed for this record.

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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03944174
Lead sponsor
Assiut University
Responsible party
Mohammed Elhady Hassan Mohammed Ali (Physician, Assiut University) — Principal investigator
First posted
May 9, 2019
Start date
Jun 2019 (estimated)
Primary completion
Feb 2020 (estimated)
Completion
Jun 2020 (estimated)
Last update
May 10, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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