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

Acetabular Fracture Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05606042
Study type Observational
Source CurvaFix, Inc.
Contact Jennifer Hebert
Phone 16504001837
Email jennifer@clin-assist.com
Status Recruiting
Phase
Start date November 24, 2021
Completion date June 2024
View Details
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