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Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

NCT05426356 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-10-24

No results posted yet for this study

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

Conditions

  • Fracture;Pelvis
  • Sacral Fracture
  • Sacroiliac; Fusion
  • Fragility Fracture
  • Insufficiency Fractures
  • Osteoporosis

Interventions

DEVICE

Surgical Intervention

Surgical sacral fracture fixation and SI joint fusion using iFuse-TORQ

OTHER

Non-Surgical Management

Non-surgical management (NSM) is any treatment deemed appropriate for the subject that does not involve surgery.

Sponsors & Collaborators

  • SI-BONE, Inc.

    lead INDUSTRY

Principal Investigators

  • Robyn Capobianco, PhD · SI-BONE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-18
Primary Completion
2024-06-15
Completion
2024-06-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05426356 on ClinicalTrials.gov