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Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Recruitment opened Show 4 more changesShow less
    • Start date changed from estimate of May 1, 2026 to Sep 1, 2026
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 16 of 23 entries
    • Study description revised
  2. Notable Start date: Mar 1, 2026 to May 1, 2026
    • Secondary endpoints revised (23)
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07408726
Lead Sponsor Medical University Innsbruck
Conditions
(from sponsor)
Thoracolumbar, Fractures in the Elderly
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov