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Sacral Fracture Fusion/Fixation for Rapid Rehabilitation — SAFFRON  

Osteoporosis Clinical Trial

Official title:
Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

Clinical Trial Summary

To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures

Clinical Trial Description

SAFFRON is a prospective, multicenter, randomized, controlled trial of surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint vs. nonsurgical management (NSM). The goal of the study is to demonstrate the safety, performance, effectiveness, and cost-effectiveness of use of iFuse-TORQ™ in the treatment of sacral fragility or insufficiency fractures vs. NSM. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05426356
Study type Interventional
Source SI-BONE, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date September 18, 2022
Completion date January 2025
View Details
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