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

Terminated

• Conditions: Proximal Humeral Fracture

• Registration Number: NCT03711591
• Lead Sponsor: Conventus Orthopaedics, Inc.

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.

Study Timeline

• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-18
• Study Start: 2018-11-29
• Status Verified: 2019-09
• Primary Completion: 2020-02-17
• Study Completion: 2020-02-17
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Performance Patient Assessment	Change from Baseline in Constant Murley Score at the 2 year post op	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)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States