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Lumbosacral InstabilityNCT03515239

Comparative Study Between Unillateral and Bilateral Lumbopelvic Fixation for Spinopelvic Dissociation

An observational study of Lumbosacral Instability, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lumbosacral Instability
What is being tested?
lumbopelvic fixation for spinopelvic dissociation
Type of treatment
Surgery or procedure
How many people
30 participants
Where
No sites listed yet
Study dates
1 Jun 2019to Jul 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Adult, Older adult

Study population: Skeletally mature and neurologically free patient

Who may be able to join

  • injury severity score <22
  • neurologically free patient

Who cannot join

  • injury severity score >22
  • patient with neurological injury

Trial locations and contacts

No sites are listed yet.

Essam Kamal, resident contact

01002190495

esamelbadry13@gmail.com

Mahmoud Badran, lectature contact

About this study

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.

Read the 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.

Being tested
lumbopelvic fixation for spinopelvic dissociation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lumbopelvic fixation for spinopelvic dissociationProcedure or surgery

    unilateral and bilateral lumbopelvic fixation for spinopelvic dissociation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Along a period of 12 monthes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2018
  2. Study start1 Jun 2019 (estimated)
  3. Primary completionJun 2020 (estimated)
  4. Study completionJul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03515239
Sponsor's protocol ID
spinopelvic dissociation
Status last verified
Mar 2019
First submitted
16 Apr 2018
Last updated
7 Mar 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 3338224
  • 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.

    PubMed 4089659
  • 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.

    PubMed 2338573

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbosacral Instability, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Essam Kamal, resident (01002190495, esamelbadry13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional outcomes by Majeed score (time frame: Along a period of 12 monthes.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03515239, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.

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