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

Stopped early

Conditions studied: Humeral Fractures, Proximal

In brief

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.

Key facts

Study ID

NCT03489408

Run by

Conventus Orthopaedics, Inc.

People needed

40

Starts

2018-02-01

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…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford University Hospital — Redwood City, California, United States
• Harbor-UCLA — Torrance, California, United States
• The Johns Hopkins University — Baltimore, Maryland, United States
• Snug Harbor Orthopedics — Duxbury, Massachusetts, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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