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

NCT07071870 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-04-22

No results posted yet for this study

Summary

Osteoporotic vertebral fractures (OVF) represent a significant cause of morbidity, mortality, decreased level of function and quality of life.

The most severe OVFs are unstable and in these cases surgical stabilization, with various techniques, is considered necessary to restore the physiological loading capacity of the spine, and allow fast and painless mobilization. Unfortunately, the elderly, osteoporotic patient population poses serious challenges to spinal surgery, due to tissue frailty and frequent comorbidities. The purpose of this study is to evaluate the effectiveness and safety of the SAIF intervention in comparison with multilevel surgical stabilization in participants with unstable OVFs.

Conditions

  • Unstable Osteoporotic Vertebral Compression Fractures

Interventions

PROCEDURE

Stent-screw Assisted Internal Fixation (SAIF)

Implanting vertebral body stents (VBS), followed by insertion of percutaneous, fenestrated, cement-augmented pedicular screws

PROCEDURE

Surgical stabilization

Spinal fixation with cement augmented pedicle screws bridging the fractured vertebra

Sponsors & Collaborators

  • Prof. Dr. Med. Alessandro Cianfoni, MD PhD, Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC)

    collaborator UNKNOWN

  • Eva Koetsier MD PhD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2029-12-31
Completion
2030-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07071870 on ClinicalTrials.gov