Single Center Post Approval Proximal Humerus Fixation With the Conventus Cage PH™ Device

Conventus Orthopaedics

Status: Terminated

Conditions: Proximal Humeral Fracture

Treatments: Device: Conventus Cage PH device

Study type: Observational

Funder types: Industry

Identifiers

NCT03711591

7821

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.