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

Stopped early

Conditions studied: Proximal Humeral Fracture

In brief

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.

Key facts

Study ID: NCT03711591
Run by: Conventus Orthopaedics, Inc.
People needed: 10
Starts: 2018-11-29
Expected to finish: 2020-02-17
Last updated by the study team: 2020-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient must be of at least legal age of consent according to applicable State Law.
Patient is able to understand and provide written consent

You may not qualify if…

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.

Where it is running

The University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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