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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-24

Study Completion Date

2024-06-30

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.

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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.

Conditions

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Pelvic Ring Fracture Acetabular Fracture Pelvic Fracture Pelvic Fracture Acetabulum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

IM Implant

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No