International Study on Using the Osteoporotic Fracture Classification Score to Guide Treatment Decisions for Thoracolumbar Osteoporotic Fractures

What this Trial Is About

Researchers are conducting an international multicenter prospective observational study focused on patients with symptomatic, radiologically confirmed single- or multilevel contiguous thoracolumbar T1 to L5 fractures caused by primary osteoporosis. The study includes both insufficiency fractures confirmed by MRI and low-energy traumatic fractures confirmed by CT or MRI. It aims to evaluate how well the Osteoporotic Fracture OF classification-based scoring system guides treatment decisions for these fractures, comparing outcomes when treatment aligns or does not align with the OF score recommendations. Participants will be classified using the OF system from OF 1 to OF 5 based on the severity of their fractures. Treatment decisions are categorized as either nonsurgical or surgical, with patients grouped according to whether their treatment matches the OF score guidance Accordance group or differs from it Discordance group. The initial treatment decision day is designated as Day 0, and patients will be followed clinically at discharge, 6 weeks, 3 months, 6 months, and 12 months. Surgical interventions may include various types of posterior stabilization procedures with or without augmentation or osteotomy. During the study, participants will undergo assessments to measure their return to mobility, which is the primary outcome within the first 3 months after treatment. Secondary outcomes include evaluations of clinical status, pain levels, daily activities, quality of life, and complications related to surgery or fracture subtype over a 12-month period. Researchers will collect data through clinical follow-ups at specified intervals, tracking treatment type, functional recovery, and patient satisfaction. The total follow-up duration extends up to one year to monitor long-term results and health economic impacts.

The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures