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.