Evaluation of Curvafix® System for Fixing Pelvic and Acetabular Fractures
Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Performance Evaluation
This study is testing how well the Curvafix system works for fixing pelvic fractures in patients who had surgery within the last month to see if it helps with healing and mobility over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | CurvaFix, Inc. Industry-sponsored |
| Locations | 4 sites (Springfield, Illinois and 3 other locations) |
| Trial ID | NCT05606042 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the performance of the Curvafix intramedullary system for pelvic fixation in patients who have undergone surgery within the last 30 days. Participants will have their medical records reviewed to assess outcomes such as pelvic reduction stability, fracture healing, and mobility over a six-month follow-up period. The study aims to document any secondary surgical interventions as a primary endpoint, with no additional patient participation required beyond standard care.
Who should consider this trial
Good fit: Ideal candidates are patients who have recently undergone pelvic or acetabular fixation using the Curvafix IM Implant.
Not a fit: Patients who are unable to provide informed consent or have conditions that may interfere with their participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of the effectiveness and safety of the Curvafix system in treating pelvic and acetabular fractures.
How similar studies have performed: While this study is a post-market evaluation, similar approaches have shown promise in evaluating new surgical implants, suggesting potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Springfield, Illinois and 3 other locations
- Memorial Medical Center, Springfield — Springfield, Illinois, United States (Recruiting)
- Missouri Orthopaedic Institute — Columbia, Missouri, United States (Recruiting)
- Mount Carmel Research Institute — Columbus, Ohio, United States (Recruiting)
- UT Health San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Jennifer Hebert
- Email: jennifer@clin-assist.com
- Phone: 16504001837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.