Post-Approval Prospective Study - Conventus CAGE™ PH for Use in Proximal Humerus Fracture Fixation



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:February 1, 2018
End Date:February 2022
Contact:Carrie Hill
Email:chill@conventusortho.com
Phone:855-418-6466

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Post-Approval Prospective Study - Conventus CAGE™ PH for Use in Proximal Humerus Fracture Fixation - Study ID 5807

The purpose of this study is to collect device and procedure experience in everyday clinical
practice. The patients are being asked to participate in this study because they are a
surgical candidate for the treatment of a broken shoulder and are considering treatment with
the PH Cage device.

The Conventus CAGE™ PH (PH Cage) System Post-Approval Prospective Study (Study) is a
multi-center, prospective, post-approval clinical study designed to collect device and
procedure experience in everyday clinical practice.

Specifically, the study will provide:

1. Device safety and patient outcome data.

2. Device usage data.

3. Performance data for the implant procedure.

4. Publications.

5. Early economic benefit data.

Patient Assessments Demographic and general health data will be collected on all patients at
the baseline appointment to ensure subjects meet inclusion/exclusion criteria. In addition,
to these data, x-rays and adverse event reports related to the implanted device, surgical
procedure and/or study data collection methods will be collected.

Patients will be seen at baseline, 2-, 6- and 12-week, 1- and 2-year post op.

Patient participation in this study is voluntary. However, post-implant patient follow-up
adds to the medical community's understanding of proximal humerus fracture patient outcomes,
as well as the safety and performance of the PH Cage.

Inclusion Criteria:

The following criteria, in accordance with the product labelling (Instructions For Use),
should be considered when selecting patients for inclusion in this Study:

- Patient must be of at least legal age of consent according to applicable State Law.

- Patient is able to understand and provide written consent.

- Patient is willing and able to cooperate with post-operative instructions, including
follow-up examinations and limitations of strenuous activities involving the injured
extremity.

Exclusion Criteria:

- The PH Cage should not be implanted in patients with suspected or known allergies to
titanium or nickel.

- Patients with open wound fractures.

- Patients with ipsilateral injures or concomitant operation(s) that will have a
material impact on the study. Such injuries/ operations are those that affect general
health status or the function of the injured extremity.

- Pregnant patients.

- Patients with current or history of mental illness and/or dementia.

- Patients with current or history of alcoholism and/or chemical substance abuse.

- Patient has a medical condition(s) that precludes 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 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
9
sites
Minneapolis, Minnesota 55414
Principal Investigator: Nancy Luger, MD
Phone: 612-873-4634
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Uma Srikumaran, MD, MBA
Phone: 443-546-1555
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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Annapolis, Maryland 21401
Principal Investigator: Jeffrey Gelfand, MD
Phone: 443-481-5757
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Annapolis, MD
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Cincinnati, Ohio 45267
Principal Investigator: John Wyrick, MD
Phone: 513-558-6077
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Duxbury, Massachusetts 02332
Principal Investigator: Walter Stanwood, MD
Phone: 781-394-2350
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Duxbury, MA
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Rancho Mirage, California 92270
Principal Investigator: Patrick St. Pierre, MD
Phone: 760-766-2540
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Redwood City, California 94063
Principal Investigator: Julius Bishop, MD
Phone: 650-721-7613
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Redwood City, CA
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Principal Investigator: Jonah Hebert-Davies, MD
Phone: 206-940-2141
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Seattle, WA
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Torrance, California 90502
Principal Investigator: Christopher Hoshino, MD
Phone: 310-222-1681
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Torrance, CA
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