Actively Recruiting

Phase Not Applicable
Age: 20Years - 75Years
All Genders
ID07516834

3D Gait Analysis and Electromyography After Instrumented Stabilisation of Thoracolumbar Spine Fractures Comparing Open and Minimally Invasive Surgical Approaches

Led by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. · Updated on 2026-04-08

20

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with fractures in the thoracic or lumbar spine who need surgical stabilization using instrumented posterior methods. The study compares two surgical approaches: a traditional open procedure and a minimally invasive surgery. The goal is to understand potential differences in how patients recover their natural walking ability over time after these surgeries. Participants will be randomly assigned to receive either the open approach or minimally invasive posterior spine stabilization, involving the use of transpedicular screws. The study includes detailed analysis of walking patterns using three-dimensional gait analysis and muscle activity monitoring through electromyography of deep back muscles. These assessments are conducted at several time points, from two weeks up to one year after surgery. During the study, participants will undergo scheduled evaluations where their gait and muscle function are measured to track recovery progress. The main outcome is the Gait Profile Score measured from two weeks to one year after surgery, while electromyography provides additional insight into muscle recovery. The study runs from early 2022 until mid-2026, with ongoing monitoring to assess the effectiveness of each surgical approach in restoring physiological gait.

CONDITIONS

Brief Title

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.

Who Can Participate

Age: 20Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Fracture of thoracic or lumbar spine indicated for spine stabilization
Not Eligible

You will not qualify if you...

  • Neurological deficits caused by the primary spine trauma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 2 weeks or until discharge

Participants undergo spine stabilization surgery using either an open or minimally invasive approach.

1 surgical visit and immediate postoperative care

Post-operative Follow-up

Duration - From 2 weeks postoperative to 1 year postoperative

Participants attend follow-up visits for gait analysis and electromyography to assess recovery after surgery.

Multiple visits for gait and electromyography assessments over 1 year

Trial Site Locations

Total: 1 location

1

Krajska zdravotni, a.s., Masarykova nemocnice hospital in Usti nad Labem, Ústí Nad Labem, Ustecky kraj 40001

Ústí nad Labem, Ústí nad Labem Region, Czechia, 40001

Actively Recruiting

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Research Team

J

Jan Soukup, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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