NCT05606042

Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Evaluation

Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Performance Evaluation

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 53 (actual)
• Sponsor: CurvaFix, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting.

Detailed description

This study will evaluate the use and performance of the Curvafix IM intramedullary system for pelvic fixation in a post-market setting. Study participants will undergo follow-up care per institutional practice and data will then be collected from participant medical records. There will be no active patient participation requirements outside of standard of care. Any follow up evaluations will be documented and reported through 6 months post-implantation. The study will evaluate secondary surgical interventions as a primary study endpoint. Data will also be collected and analyzed for pelvic reduction stability, fracture healing, participant mobility/ambulation, and general health economics.

Conditions

• Pelvic Ring Fracture
• Acetabular Fracture
• Pelvic Fracture
• Pelvic Fracture Acetabulum

Interventions

Type	Name	Description
DEVICE	IM Implant	Patients that have had surgical interventions with one or more IM Implant as part of standard of care for a pelvic and/or acetabular fracture

Timeline

• Start date: 2021-11-24
• Primary completion: 2023-03-09
• Completion: 2023-03-09
• First posted: 2022-11-04
• Last updated: 2026-03-20

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study