Single Center Post Approval Proximal Humerus Fixation With the Conventus Cage PH™ Device
The Conventus CAGE™ PH (PH Cage) System Post-Approval Observational Data Collection Study (Study) is a single center, prospective, post-approval clinical study designed to collect device and procedure experience in everyday clinical practice.
- Proximal Humeral Fracture
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Patient must be of at least legal age of consent according to applicable State Law.
- Patient is able to understand and provide written consent
- The PH Cage should not be implanted in patients with suspected or known allergies to titanium or nickel.
- Pregnant female patients.
- Patients with current or history of mental illness and/or senility.
- Patients with current or history of alcoholism and/or chemical substance abuse.
- Patient has a medical condition(s) that preclude cooperation with the rehabilitation regimen.
- Patient has active infection at the operative site or other active systemic infection.
- Patient has a pathologic proximal humerus fracture.
- Patients proximal humerus fracture extends into the diaphysis.
- Patient has associated glenohumeral dislocation.
- Patient has known pre-existing rotator cuff disease.
- Patient has ipsilateral injury or concomitant surgery that will have a material impact on the study, such that the injury/surgery affects the patients' health status or the function of the injured extremity.
- Study Type
- Observational Model
- Time Perspective
- Conventus Orthopaedics, Inc.
The study is a prospective, non-randomized, post-market approval data collection study that is designed to collect device/procedure and outcome data on patients who have experienced proximal humerus bone fractures and received a PH Cage.
Specifically, the study will provide:
1. Patient outcome and performance data for the implant and implant procedure that that may be used to support scientific publications.
2. Assurance of continued product safety and effectiveness.