Acetabular Fracture Clinical Trial
Official title:
Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Performance Evaluation
Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Missouri Orthopaedic Institute | Columbia | Missouri |
United States | Mount Carmel Research Institute | Columbus | Ohio |
United States | UT Health San Antonio | San Antonio | Texas |
United States | Memorial Medical Center, Springfield | Springfield | Illinois |
Lead Sponsor | Collaborator |
---|---|
CurvaFix, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Secondary Surgical Interventions (SSIs) | 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. | 6 months post-implantation | |
Secondary | Mobility | Mobility (ability to advance to weight bearing) assessed by medical record review | 6 months post-implantation | |
Secondary | Pelvic Reduction Stability | Pelvic reduction stability (ability to maintain reduction over time) assessed by medical record review | 6 months post-implantation | |
Secondary | Health Economics | General health economics (length of hospital stay) assessed by medical record review | 6 months post-implantation |
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