New study tests stronger screws for elderly spine fractures

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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