Single Trans-sacral Screw Versus Two Iliosacral Screws

• ClinicalTrials.gov Identifier: NCT03944174
• Recruitment Status: Unknown
• First Posted: May 9, 2019
• Last Update Posted: May 10, 2019
• Sponsor: Assiut University
• Information provided by (Responsible Party): Mohammed Elhady Hassan Mohammed Ali, Assiut University

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Pelvic Fracture	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 Design

• Study Type: Observational
• Estimated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Comparative Study Between Single Trans-sacral Screw Versus Two Iliosacral Screws in Fixation of Unstable Pelvic Fractures
• Estimated Study Start Date: June 2019
• Estimated Primary Completion Date: February 2020
• Estimated Study Completion Date: June 2020

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Early painless weight bearing as tolerated measured by Visual Analogue Scale of Pain (VAS). [ Time Frame: 2 weeks ]
   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. To measure the functional outcome using Majeed Pelvic Score system [ Time Frame: 6 weeks and 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: 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

Criteria

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.".

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Visual Analogue Scale of Pain 

Majeed Pelvic Score 

• Responsible Party: Mohammed Elhady Hassan Mohammed Ali, Physician, Assiut University
• ClinicalTrials.gov Identifier: NCT03944174
• Other Study ID Numbers: Trans-sacral screw fixation
• First Posted: May 9, 2019
• Last Update Posted: May 10, 2019
• Last Verified: May 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hip Fractures; Fractures, Bone; Wounds and Injuries; Femoral Fractures; Hip Injuries; Leg Injuries