NCT07516834

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2022

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

April 1, 2026

Last Update Submit

April 1, 2026

Conditions

Spine Fracture

Outcome Measures

Primary Outcomes (1)

  • 3D Gait Analysis - Gait Profile Score

    2 weeks postoperative - 1 year postoperative

Secondary Outcomes (1)

  • Electromyography of deep-plane spine muscles

    2 weeks postoperative - 1 year postoperative

Study Arms (2)

Open approach posterior stabilization of either thoracic or lumbar spine fracture

ACTIVE COMPARATOR
Procedure: spine stabilization

Minimally invasive approach posterior stabilization of either thoracic or lumbar spine fracture

ACTIVE COMPARATOR
Procedure: spine stabilization

Interventions

spine stabilizationPROCEDURE

transpedicular screws posterior spine stabilization

Minimally invasive approach posterior stabilization of either thoracic or lumbar spine fractureOpen approach posterior stabilization of either thoracic or lumbar spine fracture

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fracture of thoracic or lumbar spine indicated for spine stabilization

You may not qualify if:

  • neurological deficits as a consequence of the primary spine trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ústí nad Labem, Ústecký kraj, 40001, Czechia

RECRUITING

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Jan Soukup, M.D.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Soukup, M.D.

CONTACT

+420723705376Soukup07@kzcr.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 8, 2026

Study Start

February 20, 2022

Primary Completion

June 1, 2026

Study Completion

July 1, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)