Clinical trial NCT03711591: Single Center Post Approval Proximal Humerus Fixation With the Conventus Cage PH™ Device
Official title: Proximal Humerus Fixation With the Conventus Cage™ PH Device A Post-Approval Observational Data Collection Study, A Single-Center Study, Memorial Hermann
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Proximal Humeral Fracture
Keywords: Proximal humerus fracture fixation
Trauma
Proximal Humerus
Fixation
Lead sponsor: Conventus Orthopaedics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be enrolled from the community in which the study is being conducted.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Performance Patient Assessment
timeFrame: Change from Baseline in Constant Murley Score at the 2 year post op
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: James M Gregory, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Conventus Orthopaedics, Inc.
name: Carrie M Hill
role: STUDY_DIRECTOR
References: