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

Humeral Fractures, Proximal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03489408
• Other study ID #: 5807
• Status: Terminated
• Start date: February 1, 2018
• Est. completion date: February 17, 2020

Study information

• Verified date: January 2020
• Source: Conventus Orthopaedics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: February 17, 2020
• Est. primary completion date: February 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Humeral Fractures, Proximal
• Shoulder Fractures

Intervention

Device:
• Conventus Cage™ PH
Proximal humeral fracture fixation

Locations

Country	Name	City	State
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	Stanford University Hospital	Redwood City	California
United States	Harbor-UCLA	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Conventus Orthopaedics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary performance patient assessment	Constant Murley Score	Change from Baseline in Constant Murley Score at 2-year post-op