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Recruiting NCT07516834

Three Dimensional Gait Analysis and Electromyography After Stabilisation of Thoracolumbar Spine Fractures Focusing on Possible Temporal Diferences in Physiological Gait Recovery Through Comparison of Open and Minimally Invasive Approaches.

No phase Interventional Spine Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: spine stabilization.
Who it may be relevant to
Registry conditions: Spine Fracture. Basic parameters: 20 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

3D Gait Analysis and Electromyography After Instrumented Stabilisation of Thoracolumbar Spine Fractures - Comparison Between Open and Minimally Invasive Approach

Overview

We prospectively enrolled patients with a thoracic or lumbar spine fracture indicated for instrumented posterior stabilization. We consequently randomized the patient for either a conventional open approach procedure or minimally invasive surgery. 3DGA analysis was carried out at specific time points after surgery together with electromyography of deep-plane back muscles.

Interventions

  • Procedure spine stabilization
    transpedicular screws posterior spine stabilization

Primary outcome measures

  • 3D Gait Analysis - Gait Profile Score [Time frame: 2 weeks postoperative - 1 year postoperative]
Secondary outcome measures (1)
  • Electromyography of deep-plane spine muscles [Time frame: 2 weeks postoperative - 1 year postoperative]

Eligibility criteria

Inclusion criteria

  • fracture of thoracic or lumbar spine indicated for spine stabilization

Exclusion criteria

  • neurological deficits as a consequence of the primary spine trauma

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • Krajska zdravotni, a.s., Masarykova nemocnice hospital in Usti nad Labem, Ústí Nad Labem, — Ústí nad Labem

Identifiers

NCT: NCT07516834 · 3DGASPINE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗