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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:12/20/2018
Start Date:November 29, 2018
End Date:November 29, 2020
Contact:Carrie M Hill
Email:chill@conventusortho.com
Phone:763-515-5016

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Proximal Humerus Fixation With the Conventus Cage™ PH Device A Post-Approval Observational Data Collection Study, A Single-Center Study, Memorial Hermann

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.

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.

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.
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: James M Gregory, MD
Phone: 713-486-1886
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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from
Houston, TX
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