RCT on the Efficacy and Safety of Minimally Invasive SAIF Technique vs Spinal Fixation in Unstable Osteoporotic Vertebral Fractures

Launched by EVA KOETSIER MD PHD · Jul 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical methods to treat unstable fractures in the bones of the spine caused by osteoporosis, a condition that weakens bones. These fractures can cause significant pain and make it hard to move around. The trial compares a newer, less invasive surgery called the SAIF technique with the more traditional spinal fixation surgery to see which one is safer and works better in helping patients recover.

People who may be eligible for this study are adults with one or two unstable spinal fractures caused by osteoporosis, confirmed by imaging tests, and who experience pain when moving. They must be able to understand and communicate in the local language and agree to take part. The study excludes those with certain nerve problems, infections, cancer in the spine, serious mental health issues, or those who might not be able to follow the study rules. Participants can expect to receive one of the two types of surgery and will be closely monitored to see how well they heal and how safe each treatment is. This trial aims to help improve care for older adults with these difficult-to-treat spinal fractures.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • one to two unstable OVFs\* type OF 3-5\*\* as assessed on CT scan, located between T2 and L5, of age \<3 months or with persistent edema on STIR, or with pseudarthrosis, at the index level
• • patients reporting pain upon mobilization
• • a diagnosis of osteoporosis, based on a DEXA T-score ≤ -2.5, or on a spontaneous thoracolumbar vertebral fracture or a vertebral fracture caused by minor trauma
• • able to read and speak the official language of the region of the site,
• • informed consent
• • additional OVF without unstable features (OF 1-2) allowed \*\* OF-Classification
• Exclusion Criteria:
• • compressive neurologic symptoms such as myelopathy or radiculopathy with motor deficit
• • acute infection
• • spinal malignancy
• • comorbid severe psychiatric conditions
• • known or suspected non-compliance, drug or alcohol abuse
• • known hypersensitivity or allergy to the investigational product
• • inability to follow the procedures of the study