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

NCT03711591 | Terminated FDA Device

• 1 other identifier: 7821
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Humeral Fracture

Keywords

Proximal humerus fracture fixation; Trauma; Proximal Humerus; Fixation

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Conventus Cage PH device 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patient must be of at least legal age of consent according to applicable State Law.
• Patient is able to understand and provide written consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Conventus Orthopaedics, Inc.: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Shoulder Fractures; Wounds and Injuries

Condition Hierarchy (Ancestors)

Fractures, Bone; Shoulder Injuries

Study Officials

• James M Gregory, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Carrie M Hill

  Conventus Orthopaedics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 18, 2018
• Study Start: November 29, 2018
• Primary Completion: February 17, 2020
• Study Completion: February 17, 2020
• Last Updated: February 20, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• Access Criteria: Data will be publicly available via any publications developed from this study.

Locations

US (1)