Comparing open and minimally invasive posterior stabilization for thoracic and lumbar spine fractures using 3D gait and muscle recordings
3D Gait Analysis and Electromyography After Instrumented Stabilisation of Thoracolumbar Spine Fractures - Comparison Between Open and Minimally Invasive Approach
This trial will test whether open or minimally invasive posterior stabilization leads to faster or different walking and back-muscle recovery after thoracic or lumbar spine fractures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. Academic / other |
| Locations | 1 site (Ústí nad Labem, Ústí nad Labem Region) |
| Trial ID | NCT07516834 on ClinicalTrials.gov |
What this trial studies
This single-center, prospective randomized trial enrolled patients with thoracic or lumbar spine fractures who required instrumented posterior stabilization and randomized them to either a conventional open approach or a minimally invasive surgical approach. Patients underwent three-dimensional gait analysis and electromyography of deep back muscles at predefined postoperative time points to track temporal patterns of physiological gait recovery. The protocol excluded patients with neurological deficits resulting from the initial trauma to focus on recovery of musculoskeletal function. All procedures and follow-up testing were performed at Masarykova Nemocnice in Ústí nad Labem, Czech Republic.
Who should consider this trial
Good fit: Adults with a thoracic or lumbar spine fracture who are planned for instrumented posterior stabilization and who do not have neurological deficits from the initial injury.
Not a fit: Patients with neurological deficits from the primary spine trauma, those whose fractures do not require posterior stabilization, or those unable to attend the single-center follow-up testing are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could guide surgeons toward the approach that speeds restoration of normal walking and back-muscle function, improving rehabilitation and patient outcomes.
How similar studies have performed: Previous work has suggested minimally invasive posterior approaches can reduce soft-tissue damage and early pain, but detailed randomized comparisons using 3D gait analysis and deep-muscle EMG are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ústí nad Labem, Ústí nad Labem Region
- 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 (Recruiting)
Study contacts
- Principal investigator: Jan Soukup, M.D. — Krajska zdravotni, a.s., Masarykova nemocnice hospital in Usti nad Labem, Ústí Nad Labem, Ustecky kraj 40001
- Study coordinator: Jan Soukup, M.D.
- Email: Soukup07@kzcr.eu
- Phone: +420723705376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.