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

Recruiting

• Conditions: Acetabular Fracture; Pelvic Fracture; Pelvic Ring Fracture; Pelvic Fracture Acetabulum
• Interventions: Device: IM Implant

• Registration Number: NCT05606042
• Lead Sponsor: CurvaFix, Inc.

Brief 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.

Study Timeline

• Study Start: 2021-11-24
• Study First Submitted: 2022-10-31
• Study First Submitted QC: 2022-10-31
• Study First Posted: 2022-11-04
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-09
• Last Update Posted: 2023-06-12
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Subject, or their Authorized Representative, is willing and able to provide written informed consent, including authorization to release health information
• Subject has undergone pelvic or acetabular fixation using the IM Implant and the IM Implant was placed according to the manufacturer's labeling.
• Subject's pelvic or acetabular fixation with the IM Implant occurred within the last 30 calendar days.

Exclusion Criteria

• Subject is unwilling or unable to provide written informed consent and/or does not have an authorized representative who can provide consent on their behalf
• Subject presents with any condition or situation which, in the Investigator's opinion, puts the Subject at risk, could confound the study results, or may interfere with the Subject's participation in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IM Implant	IM Implant	Male and female patients who present with a pelvic ring and/or acetabular fracture that has recently undergone surgery to be fixed with a CurvaFix IM Implant.

Primary Outcome Measures

Name	Time	Method
Secondary Surgical Interventions (SSIs)	6 months post-implantation	Performance will be evaluated based upon the number of Secondary Surgical Interventions (SSIs) that occur within the subject's participation as identified through a review of subject medical records.

Secondary Outcome Measures

Name	Time	Method
Pelvic Reduction Stability	6 months post-implantation	Pelvic reduction stability (ability to maintain reduction over time) assessed by medical record review
Mobility	6 months post-implantation	Mobility (ability to advance to weight bearing) assessed by medical record review
Health Economics	6 months post-implantation	General health economics (length of hospital stay) assessed by medical record review

Trial Locations

Locations (4)

Missouri Orthopaedic Institute; 🇺🇸 Columbia, Missouri, United States

Mount Carmel Research Institute; 🇺🇸 Columbus, Ohio, United States

Memorial Medical Center, Springfield; 🇺🇸 Springfield, Illinois, United States

UT Health San Antonio; 🇺🇸 San Antonio, Texas, United States