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

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

Detailed Description
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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.

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

Conditions
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Pelvic Ring Fracture, Acetabular Fracture, Pelvic Fracture, Pelvic Fracture Acetabulum

Intervention / Treatment
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* Device: IM Implant


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IM Implant<br>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. | Device: IM Implant<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Surgical Interventions (SSIs) | 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. | 6 months post-implantation | 

Secondary Outcome Measures

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