Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Evaluatio
Not Applicable
Recruiting
- Conditions
- Pelvic Ring FractureAcetabular FractureInjuries and Accidents - FracturesMusculoskeletal - Other muscular and skeletal disordersSurgery - Other surgery
- Registration Number
- ACTRN12622001125718
- Lead Sponsor
- CurvaFix, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. [Approximately 6 months post-implantation]
- Secondary Outcome Measures
Name Time Method Mobility (ability to advance to weight bearing) assessed by medical record review[Approximately 6 months post-implantation];Subject Mobility/Ambulation (time to ambulation) assessed by medical record review[Approximately 6 months post-implantation];Pelvic reduction stability (ability to maintain reduction over time) assessed by medical record review[Approximately 5 months post-implantation];General health economics (length of hospital stay) assessed by medical record review[Approximately 6 months post-implantation]