Monoaxial vs. Polyaxial Hybrid Stabilization for Thoracolumbar Fractures in Older Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares two screw designs—monoaxial and polyaxial—used in percutaneous bisegmental hybrid stabilization with cement-augmented pedicle screws and balloon kyphoplasty for thoracolumbar fractures in patients aged 60 and older. It seeks to determine differences in radiographic alignment, kyphosis correction, and clinical outcomes between the two approaches. Eligible participants have acute fractures between T11 and L4 and are suitable for this minimally invasive stabilization method. The study is conducted at a single center with experienced spinal surgeons and follows patients longitudinally to assess early mobilization, deformity correction, and functional recovery. Primary and secondary outcomes focus on radiographic measures and patient-reported outcomes over follow-up visits.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patient-related criteria:

1. Age ≥ 60 years (male and female patients)
2. Ability to understand nature, risks, and benefits of study participation and to provide written informed consent.
3. Psychosocially, mentally, and physically capable of complying with all study requirements, including scheduled follow-up visits, completion of forms, and participation in all procedures as defined by the protocol.
4. Ambulatory prior to fracture, with or without the use of assistive devices

Fracture-related criteria:

1. Acute vertebral fractures located between T11 and L4 (inclusive)
2. Fractures deemed suitable for bisegmental hybrid stabilization based on clinical and radiological assessment - primarily OF type 3 and type 4 fractures according to DGOU classification; type 2 and 5 fractures may also be included based on individual evaluation, with the final treatment decision left to the discretion of the treating surgeon.

Exclusion Criteria:

Patient-related criteria:

1. Body mass index (BMI) \> 35
2. Permanent or progressive neurologic deficits (including upper motor neuron disease and myelopathy)
3. Rheumatoid arthritis or known disorders of bone metabolism (excluding osteopenia/osteoporosis, Vitamin D deficiency)
4. History of radiation therapy to the spine
5. History of alcohol or drug abuse within the last 2 years prior to randomization
6. Current therapy with high-dose systemic corticosteroids (e.g., \>10 mg/day prednisone equivalent for more than 3 months)
7. Ongoing or planned treatment with cytotoxic chemotherapy (excluding biologicals, immunotherapy, or targeted agents) at the time of enrollment
8. Known allergy to any component of the spinal instrumentation
9. Participation in other clinical investigations (drug or device) that may interfere with the outcomes of this study

Fracture-related criteria:

1. Vertebral fractures associated with neurological deficits
2. Fracture age \> 4 weeks at the time of enrollment
3. Pathological fractures due to spinal infection or metastatic bone disease
4. Planned major spinal surgery within 12 months of enrollment
5. Severe spinal deformities or fusion at the index or adjacent segments
6. Previous spinal surgery involving the index or adjacent vertebrae, with the exception of minor non-instrumented procedures, such as simple sequestrectomies or decompressions

Where it's running

• Univ.-Klinik für Orthopädie und Traumatologie
  Innsbruck, Tyrol, Austria Recruiting

Study contacts

• Study coordinator: Mariette Widner, MSc
• Email: lki.ot.studienkoordination@tirol-kliniken.at
• Phone: 0512 504 80328

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.