Single Center Post Approval Proximal Humerus Fixation With the Conventus Cage PH™ Device
Purpose
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.
Condition
- Proximal Humeral Fracture
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patient must be of at least legal age of consent according to applicable State Law. - Patient is able to understand and provide written consent
Exclusion Criteria
- 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 Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
More Details
- Status
- Terminated
- Sponsor
- Conventus Orthopaedics, Inc.
Study Contact
Detailed Description
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.