Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorMedical University Innsbruck

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 60 years (male and female patients)

Ability to understand nature, risks, and benefits of study participation and to provide written informed consent.

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.

Ambulatory prior to fracture, with or without the use of assistive devices

Disqualifiers

Body mass index (BMI) > 35

Permanent or progressive neurologic deficits (including upper motor neuron disease and myelopathy)

Rheumatoid arthritis or known disorders of bone metabolism (excluding osteopenia/osteoporosis, Vitamin D deficiency)

History of radiation therapy to the spine

Trial design

Treatments tested in this trial

  • Monoaxial instrumentation - the M.U.S.T. Monoaxial Pedicle Screw Cannulated (Medacta International SA, Switzerland)
  • Polyaxial instrumentation - the M.U.S.T. LT Pedicle Screw System (Medacta International SA, Switzerland)

Treatment groups

44 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators