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

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.

Study Overview

• Status: Terminated
• Conditions: Humeral Fractures, Proximal
• Intervention / Treatment: Device: Conventus Cage™ PH

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford University Hospital
    • Torrance, California, United States, 90509
      • Harbor-UCLA
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • The Johns Hopkins University
  • Massachusetts
    • Duxbury, Massachusetts, United States, 02332
      • Snug Harbor Orthopedics
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study is a prospective, single arm study of patients who are indicated for and have received an FDA cleared Conventus PH Cage.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary performance patient assessment	Constant Murley Score	Change from Baseline in Constant Murley Score at 2-year post-op

Collaborators and Investigators

• Sponsor: Conventus Orthopaedics, Inc.
• Investigators: Study Director: Carrie Hill, Conventus Orthopaedics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): February 17, 2020
• Study Completion (Actual): February 17, 2020

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: trauma; Proximal humerus fracture fixation
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: 5807

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No