Comparative Study Between Unillateral and Bilateral Lumbopelvic Fixation for Spinopelvic Dissociation

Lumbopelvic fixation is the treatment opation for spinopelvic dissociation. In our study we will compare unilateral versus bilateral lumbopelvic fixation as regarding functional outcomes by Majeed score along a period of 12vmonths as a primary measure and metal failure,skin condition and nonunion as secondaries.

Study Overview

• Status: Unknown
• Conditions: Lumbosacral Instability
• Intervention / Treatment: Procedure: lumbopelvic fixation for spinopelvic dissociation

Detailed Description

Traumatic loss of connection between the spine and pelvis can adopt many forms including lumbosacral fracture dislocation and bilateral sacroiliac dislocation. However, the term spinopelvic dissociation refers to a pathological condition in which this dissociation occurs due to the association of a transverse fracture with sagittal fractures in both sacral wings, result-ing in a proximal segment with the vertebral spine and the proximal sacral fragment, which is mechanically separated from a distal segment formed by the pelvic girdle and the rest of the sacrum.

Spinopelvic dissociation is an important entity to recognize because these fractures are almost uniformly unstable with a very narrow set of criteria for conservative management .

The mechanism of injury includes a very high energy trauma with axial compression on the sacrum.

Various options for internal fixation have been proposed, including percutaneous iliosacral screws, transiliac bars, sacral rods, posterior small plates, or vertical stabilization alone .

Some authors have introduced the technique of triangular posterior osteosynthesis (TPO) in the treatment of vertically unstable pelvic fracture..This is a biplanar fixation able to counterbalance the forces on the posterior pelvic ring during unipodal stance, so as to allow early weight-bearing. The stability of fixation could be confirmed by biomechanical testing of human specimens with transforaminal sacral fractures submitted to cyclic loading. The load to failure of the commonly used internal fixation techniques (sacroiliac screw fixation, plating limited to the sacrum) amounted to 60% of the load to failure of triangular stabilizations. In order to perform the triangular osteosynthesis, we used the Click'X system (Synthes, Oberdorf, Switzerland). Pedicle screws were first inserted in the pedicle of L4. Subsequently caudal screws were implanted into the iliac bone, through the posterior-superior-iliac-spine and parallel to the sacroiliac joint. Once the four screws were inserted, reduction was carried out. Connecting rods were inserted and tightened initially only over the proximal pedicle screws of L4.

The pedicle screws were used as ''joysticks'' in order to achieve reduction in the vertical and horizontal direction at this point, the connecting rod was tightened over the distal screws, therefore stabilizing the fracture. In order to obtain stabilization in the horizontal plane a 6-mm rod was inserted as atransversal cross-link between the two longitudinal connecting rods.e used the Click'X system (Synthes, Oberdorf, Switzerland). Pedicle screws were first inserted in the pedicle of L4. Subsequently caudal screws were implanted into the iliac bone, through the posterior-superior-iliac-spine and parallel to the sacroiliac joint. Once the four screws were inserted, reduction was carried out. Connecting rods were inserted and tightened initially only over the proximal pedicle screws of L4.

The pedicle screws were used as ''joysticks'' in order to achieve reduction in the vertical and horizontal direction at this point, the connecting rod was tightened over the distal screws, therefore stabilizing the fracture. In order to obtain stabilization in the horizontal plane a 6-mm rod was inserted as a transversal cross-link between the two longitudinal connecting rods.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Skeletally mature and neurologically free patient

Description

Inclusion Criteria:

• injury severity score <22
• neurologically free patient

Exclusion Criteria:

• injury severity score >22
• patient with neurological injury

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcomes by Majeed score	Functional outcomes by Majeed score in group of patient with spinopelvic dissociation fixed by unilateral triangular osteosynthesis and comparing them with group of patient fixed by bilateral triangular osteosynthesis.	Along a period of 12 monthes.

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Denis F, Davis S, Comfort T. Sacral fractures: an important problem. Retrospective analysis of 236 cases. Clin Orthop Relat Res. 1988 Feb;227:67-81.
• Roy-Camille R, Saillant G, Gagna G, Mazel C. Transverse fracture of the upper sacrum. Suicidal jumper's fracture. Spine (Phila Pa 1976). 1985 Nov;10(9):838-45. doi: 10.1097/00007632-198511000-00011.
• Gibbons KJ, Soloniuk DS, Razack N. Neurological injury and patterns of sacral fractures. J Neurosurg. 1990 Jun;72(6):889-93. doi: 10.3171/jns.1990.72.6.0889.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: May 2, 2018
• First Posted (Actual): May 3, 2018

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Dissociative Disorders
• Other Study ID Numbers: spinopelvic dissociation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No