Single Trans-sacral Screw Versus Two Iliosacral Screws

NCT03944174 | Unknown

• 1 other identifier: Trans-sacral screw fixation
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pelvic Fracture

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Single Trans-sacral Screw

Procedure: Fixation of unstable pelvic fractures

Two Iliosacral Screws

Procedure: Fixation of unstable pelvic fractures

Interventions

Fixation of unstable pelvic fractures PROCEDURE

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

Single Trans-sacral Screw; Two Iliosacral Screws

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Links

• Visual Analogue Scale of Pain
• Majeed Pelvic Score

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: May 9, 2019
• Study Start: June 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: June 1, 2020
• Last Updated: May 10, 2019

Record last verified: 2019-05