Acetabular Fracture, Pelvic Fracture, Pelvic Fracture Acetabulum, Pelvic Ring Fracture
Conditions
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.
Interventions
DEVICEIM 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
Sponsors
CurvaFix, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mobility | 6 months post-implantation | Mobility (ability to advance to weight bearing) assessed by medical record review |
| Pelvic Reduction Stability | 6 months post-implantation | Pelvic reduction stability (ability to maintain reduction over time) assessed by medical record review |
| Health Economics | 6 months post-implantation | General health economics (length of hospital stay) assessed by medical record review |
Countries
United States
Contacts
STUDY_DIRECTORJennifer Hebert
Clin-Assist, LLC
Outcome results
None listed