Trials / Terminated
TerminatedNCT05426356
Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- SI-BONE, Inc. · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
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
Detailed 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.
Conditions
- Fracture;Pelvis
- Sacral Fracture
- Sacroiliac; Fusion
- Fragility Fracture
- Insufficiency Fractures
- Osteoporosis
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-09-18
- Primary completion
- 2024-06-15
- Completion
- 2024-06-15
- First posted
- 2022-06-22
- Last updated
- 2024-10-24
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05426356. Inclusion in this directory is not an endorsement.