Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Evaluation
Purpose
Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting.
Conditions
- Pelvic Ring Fracture
- Acetabular Fracture
- Pelvic Fracture
- Pelvic Fracture Acetabulum
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- CurvaFix, Inc.
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.