Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03515239 |
| Other study ID # |
spinopelvic dissociation |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
July 2020 |
Study information
| Verified date |
March 2019 |
| Source |
Assiut University |
| Contact |
Essam Kamal, resident |
| Phone |
01002190495 |
| Email |
esamelbadry13[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
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.
