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 |
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.
(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.
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
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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