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.

April 1, 2026 updated by: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Ústecký kraj
      • Ústí nad Labem, Ústecký kraj, Czechia, 40001
        • Recruiting
        • Krajska zdravotni, a.s., Masarykova nemocnice hospital in Usti nad Labem, Ústí Nad Labem, Ustecky kraj 40001
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • fracture of thoracic or lumbar spine indicated for spine stabilization

Exclusion Criteria:

  • neurological deficits as a consequence of the primary spine trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open approach posterior stabilization of either thoracic or lumbar spine fracture
Procedure: spine stabilization
transpedicular screws posterior spine stabilization
Active Comparator: Minimally invasive approach posterior stabilization of either thoracic or lumbar spine fracture
Procedure: spine stabilization
transpedicular screws posterior spine stabilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3D Gait Analysis - Gait Profile Score
Time Frame: 2 weeks postoperative - 1 year postoperative
2 weeks postoperative - 1 year postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Electromyography of deep-plane spine muscles
Time Frame: 2 weeks postoperative - 1 year postoperative
2 weeks postoperative - 1 year postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Investigators

  • Principal Investigator: Jan Soukup, M.D., Krajska zdravotni, a.s., Masarykova nemocnice hospital in Usti nad Labem, Ústí Nad Labem, Ustecky kraj 40001

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3DGASPINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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