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

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

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.

Study Overview

• Status: Terminated
• Conditions: Proximal Humeral Fracture
• Intervention / Treatment: Device: Conventus Cage PH device

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

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

Subjects will be enrolled from the community in which the study is being conducted.

Description

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 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 (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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2018
• Primary Completion (Actual): February 17, 2020
• Study Completion (Actual): February 17, 2020

Study Registration Dates

• First Submitted: September 27, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Trauma; Fixation; Proximal humerus fracture fixation; Proximal Humerus
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Shoulder Injuries; Arm Injuries; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: 7821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data collected will be used to support publications; all IPD that underlie results in a publication
• IPD Sharing Time Frame: The data will become available once the study concludes (>2 years from date of first enrollment, until last patient followed) Data will be publicly available via any publications developed from this study. Length of availability will be determined by the publishing party.
• IPD Sharing Access Criteria: Data will be publicly available via any publications developed from this study.
• IPD Sharing Supporting Information Type: Study Protocol

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