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

Proximal Humeral Fracture Clinical Trial

Official title:

Proximal Humerus Fixation With the Conventus Cage™ PH Device A Post-Approval Observational Data Collection Study, A Single-Center Study, Memorial Hermann

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03711591
• Other study ID #: 7821
• Status: Terminated
• Start date: November 29, 2018
• Est. completion date: February 17, 2020

Study information

• Verified date: September 2019
• Source: Conventus Orthopaedics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• 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:

• 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.

Related Conditions & MeSH terms

• Humeral Fractures
• Proximal Humeral Fracture
• Shoulder Fractures

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

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 (CMS) The Constant Murley Score is a combination of visual analog scales assessing pain, activities of daily living and assessments of range of motion and strength using a long-armed goniometer and isometer. The higher the score the better for the following sections of the CMS: A. Pain (0-15 points) (e.g.15=no pain, 2=high pain), B. Everyday activities-question 1 (0-2 points) (e.g. 2=best, 0=worst), questions 2 and 3(0-4 points) (the higher the score the better), question 4 (0-10 points) C. Movement- questions 1 and 2 (0-20 points) (e.g. the greater the range of motion performed, the more points assigned), questions 3 and 4 (0-10 points) (e.g. points assigned based on movements performed) D. Strength (0-25 points) Score is calculated from the highest score of three attempts, with each score corresponding to the force in pounds (max 25 points) The overall score is then calculated by combining all sections (A+B+C+D= 0-100 points)	Change from Baseline in Constant Murley Score at the 2 year post op