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.

ConditionSpine Fracture

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20-75

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

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

fracture of thoracic or lumbar spine indicated for spine stabilization

Disqualifiers

neurological deficits as a consequence of the primary spine trauma

Trial design

Design model

Parallel

Treatments tested in this trial

spine stabilization
Procedure/Surgery
transpedicular screws posterior spine stabilization

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Open approach posterior stabilization of either thoracic or lumbar spine fractureActive comparator 1 intervention

Group B: Minimally invasive approach posterior stabilization of either thoracic or lumbar spine fractureActive comparator 1 intervention

Trial outcomes

Primary outcomes

3D Gait Analysis - Gait Profile Score

Time frame

2 weeks postoperative - 1 year postoperative

Secondary outcomes

Electromyography of deep-plane spine muscles

Time frame

2 weeks postoperative - 1 year postoperative

Sponsors and contacts

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

Lead sponsor

Source ClinicalTrials.gov

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