None listed
Conditions
Brief summary
Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting.
Interventions
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 surgica
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.
Sponsors
CurvaFix, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has undergone pelvic or acetabular fixation using the IM Implant and the IM Implant was placed according to the manufacturer’s labeling. 2. Subject’s pelvic or acetabular fixation with the IM Implant occurred within the last 30 calendar days.
Exclusion criteria
1. 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
Outcome results
None listed