Single Trans-sacral Screw Versus Two Iliosacral Screws

Comparative Study Between Single Trans-sacral Screw Versus Two Iliosacral Screws in Fixation of Unstable Pelvic Fractures

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Fracture
• Intervention / Treatment: Procedure: Fixation of unstable pelvic fractures

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.".

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Trans-sacral Screw	Procedure: Fixation of unstable pelvic fractures; Percutaneous fixation of both iliac bones through the sacrum using one screw
Two Iliosacral Screws	Procedure: Fixation of unstable pelvic fractures; Percutaneous fixation of both iliac bones through the sacrum using one screw

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks
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.	6 weeks and 6 months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

Helpful Links

• Visual Analogue Scale of Pain

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2019
• Primary Completion (ANTICIPATED): February 1, 2020
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (ACTUAL): May 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: Trans-sacral screw fixation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No