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

NCT ID: NCT03711591

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-29
• Study Completion Date: 2020-02-17

Brief Summary

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.

Detailed Description

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.

Conditions

Proximal Humeral Fracture

Study Design

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

Interventions

Conventus Cage PH device

The Conventus CAGE™ PH (PH Cage) is a permanent implant comprised of an expandable scaffold, made from nitinol and titanium, which is deployed into the medullary canal and provides a structure to which fractured bone fragments are attached using fragment screws.

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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

James M Gregory, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Carrie M Hill

Role: STUDY_DIRECTOR

Conventus Orthopaedics, Inc.

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

7821

Identifier Type: -

Identifier Source: org_study_id