Clinical Trial

Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization

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Summary
Vertebral body fractures in older adults mostly affect the thoracolumbar junction and are challenging to treat due to osteoporosis and other comorbidities. Treatment options range from conservative approaches to minimally invasive procedures like vertebroplasty or balloon kyphoplasty, as well as surgical techniques such as posterior or combined stabilization. A common method for more severe fractures (from OF3 onwards) is percutaneous bisegmental hybrid stabilization using cement-augmented pedicle screws and balloon kyphoplasty. Polyaxial screws are easier to implant but offer less biomechanical stability. In contrast, monoaxial screws provide greater stiffness, allowing better correction of kyphosis and restoration of vertebral body height. The study compares radiological and clinical outcomes in patients aged 60 and older with thoracolumbar fractures (T11-L4) between monoaxial and polyaxial hybrid stabilization. The primary goal is to evaluate and compare the degree of kyphosis correction six months after surgery.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-06.
Trial Details
NCT Number NCT07408726
Lead Sponsor Medical University Innsbruck
Conditions Thoracolumbar, Fractures in the Elderly
Enrollment 44 participants
Start Date 2026-05-01
Primary Completion 2028-09-01 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-09