RecruitingACTRN12622001125718

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


Sponsor

CurvaFix, Inc.

Enrollment

200 participants

Start Date

Nov 24, 2021

Study Type

Observational

Conditions

Summary

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


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Pelvic and acetabular (hip socket) fractures are serious injuries that are challenging to stabilise surgically due to the complex anatomy of the pelvis. The CurvaFix intramedullary (IM) implant is a curved bone screw system specifically designed to follow the curved shape of pelvic bones, potentially offering better fixation than traditional straight implants. This post-market study evaluates how the device performs in real-world clinical use after it has already received regulatory approval. Participants are patients who have already had their pelvis or hip socket fracture fixed using the CurvaFix IM implant as part of their standard surgical care. The study collects follow-up data on healing, implant performance, and any complications that arise over time. No experimental treatment is being given — this is an observation of standard care outcomes. You may be eligible if you are 18 or older and have had your pelvic or acetabular fracture repaired using the CurvaFix IM implant within the last 30 days, according to the manufacturer's instructions.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

Illinois, Texas, Missouri, Ohio, United States of America

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ACTRN12622001125718


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