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

NCT ID: NCT03489408

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-02-17

Brief Summary

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.

Detailed Description

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.

Conditions

Humeral Fractures, Proximal

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Conventus Cage™ PH

Proximal humeral fracture fixation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conventus Orthopaedics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carrie Hill

Role: STUDY_DIRECTOR

Conventus Orthopaedics, Inc.

Locations

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

Countries

United States

Other Identifiers

5807

Identifier Type: -

Identifier Source: org_study_id