ClinicalTrials.gg
CompletedNCT03272243Updated Sep 6, 2017

Short Segment vs Long Segment Fixation in Traumatic Dorsolumbar Spine Fractures

An interventional study of short segment posterior spine fixation and long segment posterior spine fixation in SPINAL Fracture, sponsored by Ain Shams University. Completed. Per ClinicalTrials.gov, last updated 2017-09-06.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 6 months after the study started (first participant enrolled Feb 2012, registered Aug 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
91
Allocation
Randomized
Sex
All
01

Study summary

A prospective study included 91 patients, who had single level thoracolumbar fracture with Cobb's angle ≤ 25⁰, underwent posterior fixation. Forty four patients underwent short segment fixation with screws into the index level, and 47 patients underwent long segment fixation with skipped index level. The angle of correction, pain, and neurological state were regularly assessed

02

Conditions studied

  • SPINAL Fracture

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Keywords

  • thoracolumbar fracture
  • short segment fixation
  • long segment fixation
  • index level
03

In context

Spinal Fractures

144 studies on the registry are indexed under Spinal Fractures; 24 are open to participants now.

This study's enrollment of 91 is close to the median of 85 across 85 interventional studies indexed under Spinal Fractures.

Browse Spinal Fractures studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,953 studies on the registry; 430 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • wedge fracture or burst fracture with Thoraco-Lumbar Injury Classification and Severity (TLICS) score ≥ 4
  • Single level fracture
  • Less than 50% of spinal canal compromised
  • Mild kyphosis or scoliosis
  • Cobb's angle ≤ 25˚
  • with or without neurological deficit

Exclusion criteria

Exclusion Criteria:

  • patients with multiple level fractures
  • patients with more than 50% spinal canal compromise
  • patients who needed anterior approach to decompress the canal
  • patients who have fracture dislocation and / or marked kyphosis and scoliosis with Cobb's angle >25⁰
  • patients who needed 360⁰ fixation with long segment fixation to maintain the angle of correction.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
91 participants (actual)

Study arms

  • Active comparator
    Short Segment posterior spine fixation

    Short segment transpedicular screw fixation with inclusion of the index level

    Procedure: short segment posterior spine fixation

  • Active comparator
    Long Segment posterior spine fixation

    Long segment transpedicular screw fixation with escape of the index level

    Procedure: long segment posterior spine fixation

Interventions

  • Procedureshort segment posterior spine fixation
  • Procedurelong segment posterior spine fixation
06

What researchers measure

Primary outcomes

  1. Change in pain

    Visual analogue scale assessment

    Time frame: 3rd, 6th, 9th, 12th months

  2. Change in disability

    assessment of Oswestry Disability Scale

    Time frame: 3rd, 6th, 9th, 12th months

  3. Change in angle of correction

    Measurement of Cobb's angle

    Time frame: 3rd, 6th, 9th, 12th months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Clinical study report

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2012 to primary completion in Feb 2016, 48 months.

Of 36 interventional studies with no phase under Spinal Fractures, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 70. This study's 48 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2017
First posted
Sep 5, 2017
StartActual
Feb 1, 2012
Primary completionActual
Feb 28, 2016
CompletionActual
Nov 30, 2016
Last update
Sep 6, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03272243
Responsible party
Mohamed Nada (Fellow of functional neurosurgery division, Ain Shams University) — Principal investigator
First posted
Sep 5, 2017
Start date
Feb 1, 2012
Primary completion
Feb 28, 2016
Completion
Nov 30, 2016
Last update
Sep 6, 2017

Study contacts

Walid A Abdel Ghany, M.D., Ph.D
study director · Associate Professor of Neurosurgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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