NCT03489408

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Conventus Orthopaedics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Conventus Cage™ PH	Proximal humeral fracture fixation

Timeline

• Start date: 2018-02-01
• Primary completion: 2020-02-17
• Completion: 2020-02-17
• First posted: 2018-04-05
• Last updated: 2020-02-20

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study